Month: October 2022

2022-10-27T08:53:00

(BPT) – When someone has a genetic disease, the disease is lifelong. Many rare diseases are caused by a single gene not functioning correctly, and approximately 90% do not have any available treatment. Of those that do, most treatments are chronically administered, meaning a person must take the medicine on a set schedule for the remainder of their life, and such treatments are often only able to treat some of the symptoms.

However, in the past few decades, research into gene therapies has increased, and genetic medicines now have the potential to address, or correct, the non-working gene with a single administration.

Gene therapy and MPS II (Hunter syndrome)

Gene therapy is designed to deliver a functional copy of a gene into a person’s cells where there is a missing or non-working gene that is causing a disease. The goal of gene therapy is for the functional copy of the gene to begin working as it should, which is to act as an “instruction manual” for the cell to create a specific protein.

A unique characteristic of gene therapy is that it is designed to be given to a patient just one time and to have long-term effects. There are FDA-approved gene therapies that are being used to treat patients with rare genetic disorders and many more that are currently being developed and tested in human clinical trials. One disease that could potentially be addressed with a gene therapy approach is mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, a lysosomal storage disorder that occurs in 1 in 100,000 to 1 in 170,000 males.

In Hunter syndrome, the IDS gene is missing or non-functional, and the body is unable to produce the protein needed to break down large sugar molecules or cellular waste, called glycosaminoglycans (GAGs). The accumulation of GAGs in patients with Hunter syndrome causes multiple symptoms, such as joint stiffness, carpal tunnel syndrome, sleep apnea and loss of hearing. Severe Hunter syndrome results in progressive debilitation and decline in intellectual function. Currently, there are no available treatments targeting the genetic cause of Hunter syndrome.

juMPStart: A clinical trial for adults with Hunter syndrome

A clinical trial called juMPStart is evaluating an investigational gene therapy for adults with Hunter syndrome. It is designed to be given to the patient through a single intravenous (I.V.) administration, with follow-up appointments with a physician to monitor the patient’s health.

The juMPStart trial is enrolling adults with Hunter syndrome at clinical sites throughout the U.S. and Canada. Participation in this clinical trial may include enzyme replacement therapy (ERT) discontinuation. Candidates for juMPStart include Hunter syndrome patients who:

• Are male between the ages of 18-45 years
• Have a confirmed diagnosis of Hunter syndrome
• Are currently receiving ERT as treatment for Hunter syndrome

There are additional requirements to participate, which a doctor can explain. Does this sound like something you or someone you know would be interested in? If so, talk to your doctor, take this short questionnaire to see if you are a candidate for juMPStart or consider sharing the information.

2022-10-27T09:01:00

(BPT) – At its core, intuitive eating is a philosophy that encourages you to get in touch with your body and become aware of your hunger cues, according to Healthline. This approach to eating doesn’t give you a laundry list of foods that you should or should not eat. If you have avoided eating certain foods such as beans, due to diets like paleo and keto, you can take this approach as an opportunity to integrate them into your meals. Intuitive eating promotes a healthy attitude toward food without the restrictions of traditional diets.

Beans are an easy-to-use, inexpensive plant-based protein. For example, one serving of S&W Beans provides 6-7 grams of protein, which is about the same amount found in one egg or 1 ounce of meat or fish. Beans are also packed with fiber and supply several important vitamins and minerals like folate, thiamine, potassium, magnesium and iron.

If you want to eat more intuitively, or simply change up a boring meal, check out these seven recipes featuring S&W Beans.

1. Bean and Avocado Toasts

Made with S&W Jacob’s Cattle Beans, this delicious dish is perfect for a light breakfast or a fun appetizer for gatherings. These bite-sized toasted treats take just 15 minutes, combining beans, avocado and tomatoes for a fresh and filling meal.

2. Butternut Squash Cannellini Soup

As the weather starts to cool, try cooking this butternut squash and cannellini bean soup for a comforting and tasty meal. S&W Cannellini Beans are perfect for soups because of their tender and creamy texture. Paired with the nutty and slightly sweet butternut squash and topped with bacon, this soup is sure to be a crowd pleaser.

3. Yellow Eye Bean Cobb Style Salad

Featuring “tiger-eye” S&W Yellow Eye Beans, this salad is perfect as a side or as its own meal. Packed with eggs, bacon and beans, you’ll get plenty of protein from this dish. Also, the leafy romaine or baby lettuce, cherries and yellow eye beans have plenty of fiber to keep you feeling full longer.

4. Snickerdoodle Hummus

Hummus doesn’t have to be a savory side. Pureeing S&W Garbanzos with almond butter, cinnamon applesauce, sugar, cinnamon and vanilla yields a sweet and spiced dip for apple slices and cookies. Try making this yummy snack to indulge in after some fun fall activities.

5. Chicken Rice Bowls

Chicken Rice Bowls are an easy, delicious, customizable meal for lunch or dinner. While you’re cooking the rice and warming up the rotisserie chicken and S&W Pinquito Beans, chop tomatoes, avocado and cilantro. For additional toppings, add green onion, sour cream, salsa or shredded cheese. Once you have all the toppings laid out, everyone can make their own chicken rice bowl combination.

6. Mashed Garbanzo Beans

Tired of mashed potatoes? The next time you make salmon, pork, chicken or turkey, whip up some mashed S&W Garbanzos for a flavorful side dish. Garlic, cumin, paprika and red pepper flakes add a subtle kick to tantalize your taste buds. If you want to switch it up, you can substitute garbanzo beans with white beans.

7. Black Bean Spinach Pizza

You probably haven’t considered putting beans on a pizza, but it’s an easy and interesting way to add protein to a vegetarian pizza. By mixing mashed S&W Black Beans with onion, garlic, cumin, chili powder, salsa and hot sauce, you’ll have created a spicy sauce for your pizza. Topped with spinach, cilantro and cheese, this tasty combo will have you adding beans to all your homemade pizzas.

Using these seven recipes, you’ll find out just how delicious and versatile beans can be. To learn more about the different types of beans you can add to your next dish, visit Swbeans.com or the S&W Beans Amazon store.

2022-10-27T10:01:00

(BPT) – It’s no secret there’s been a spotlight on the vital work of healthcare heroes in recent years. From social media shout-outs and yard signs to daily claps and cheers, the impact of healthcare workers like nurses and doctors is recognized daily. But there are other heroes working behind the scenes to improve patients’ lives who you likely haven’t heard of. Biologic coordinators have an immeasurable impact on a patient’s life from the onset of their treatment journey and beyond treatment — yet too often, their work goes unrecognized. Care for those with immune-mediated diseases would not be possible without the incredible work of biologic coordinators. Read on to learn more about these unsung heroes and the important role they play.

What Is a Biologic Coordinator?

A biologic coordinator is a key member of a medical practice’s office staff and could be anyone, including an office administrator, physician’s assistant, nurse practitioner, or a medical assistant. They are instrumental in helping patients receive the treatment they need. Biologic coordinators can work in various healthcare roles and partner with prescribing healthcare providers, specialty pharmacies, insurance companies, and manufacturers to help their patients navigate the steps to get their prescribed biologic medication. Some biologic coordinators may not even know they are biologic coordinators!

Supporting Patients at Every Step of the Treatment Journey

While biologic therapy can be an important treatment option for patients, obtaining access to these treatments can be challenging and patients often need help navigating the process. Biologic coordinators play a multifaceted role in supporting a patient, from the moment a doctor writes a prescription, until the medicine reaches the patient, and beyond. Biologic coordinators often assist in the navigation of information requested by insurance companies, including helping to fill out and submit preauthorization forms to insurance companies on behalf of patients. Additionally, they help patients work through any coverage challenges or denials of prescribed medication, filing appeals to insurance companies on the patient’s behalf. They also work closely with the patient’s healthcare provider to get the most up-to-date information about their care, including medical records and medical history.

Support Beyond Treatment

Biologic coordinators care deeply about their patients beyond treatment. Their key role as a connection point between the patient and others allows them to know their patients on a personal level and advocate for them. Often, this deeper understanding can uncover worries about personal finances, employment, or relationships. This bond is unlike any other, and truly shows the role biologic coordinators play in improving the lives of their patients, not by a sense of obligation, but because they truly love to make a difference in people’s lives.

Advancing Care for Patients Takes a Team

Janssen established the annual National Biologic Coordinators Day last year as part of a commitment to relentlessly advance care for those with immune-mediated diseases, recognizing this can’t be done alone. The community at large continues to be inspired by the connectivity and compassion of these unsung heroes and for the individuals they work tirelessly to support. Biologic coordinators often work behind the scenes and have a deep impact on a patient’s life beyond treatment, which is why Janssen is shining a light on the crucial role they play in the healthcare journey and encourages other organizations and individuals to join in celebrating these heroes.

2022-10-20T09:29:00

(BPT) – It’s finally fall — a favorite season for so many. The leaves are changing color, the pumpkins are on the front steps, and the weather is cooling down. Unfortunately, that also means cold and flu season is here — and experts are predicting it to be a rough one.

While we tend to be more aware of our immune system during the fall and winter months when it’s put to the test, taking preventive measures to ensure your immune system is resilient all year round is just as, if not more, important. Making conscious choices around foods and healthy daily habits that support overall well-being is the best way to make immune health an everyday priority.

With studies showing a majority of consumers (65%) are more conscious of their immunity this year than previous years, Registered Dietitian Kelly Springer is sharing simple but effective strategies to implement that help build your body’s defenses as we enter cold and flu season:

Incorporate Manuka Honey Into Your Daily Routine

Manuka honey is as delicious as it is powerful. Different from traditional honey, it is a nourishing, multitasking superfood chock full of nutritional elements that the human body needs — including trace amounts of enzymes, amino acids, B Vitamins, C Vitamins, minerals and antioxidants. These are beneficial to the immune system, empower everyday wellness, aid in better digestion and provide a natural source for a daily energy boost. However, not all Manuka honey is created equal. This fall, when you start building your arsenal of immune-boosting, therapeutic remedies, consider adding a raw and authentic Manuka honey, like Wedderspoon, to that list. Wedderspoon’s Manuka Honey is fully traceable from hive to home and is the most pure and powerful form I’ve found — free of any antibiotics, glyphosates and pesticides.

I keep it on hand year-round since it’s great for so many different things, but I always stock up this time of year and begin incorporating it into my and my family’s daily routine early to help strengthen the body’s natural defenses and stave off sniffles or scratchy throats before they can start. You can add it to a warm bowl of oatmeal in the morning or cup of tea at night, use it to make your own throat-soothing cough syrup and so much more. I also never leave the house without Wedderspoon’s Manuka Honey Immunity Lozenges. They’re delicious, soothe your throat and provide a quick, on-the-go wellness boost of Vitamin C, Zinc and Epicor^® — a postbiotic that supports a healthy gut microbiome and is proven to boost your immunity in two hours.

Improve Immune Function Through Exercise and Vitamin D

I can’t think of a better way to soak up the last few rays of the sunshine season than getting outside for a quick and easy workout. Recent studies indicate that moderate intensity exercise can actually cut down on the number of colds a person gets because it increases your white blood cells, which help fight infection. Beyond that, regular exercise and Vitamin D helps moderate inflammation in the body and reduces stress, which helps keep your body’s defenses in good shape. It doesn’t have to be an intense workout — try getting outside for a 20- to 30-minute walk with a friend, biking a few times a week or doing a simple workout in your backyard.

Rethink What’s on Your Plate

My fall and winter menus always include a few key ingredients known for their immune-bolstering properties — Greek yogurt, oranges, wild salmon, herbal echinacea and dark chocolate. Greek yogurt contains probiotics that are known to fight illnesses, and oranges are always a fantastic pick-me-up as they are packed full of vitamin C. Salmon is rich in omega-3 fatty acids, which help reduce inflammation, making it one of the best proteins to eat when you’re sick. Echinacea and unsweetened dark chocolate have long been used to shorten the duration of colds to help you bounce back quicker. I love finding unique ways to incorporate these ingredients into dishes for my family — they all add delicious flavor, nutrients and vitamins that the body needs this time of year.

Practice Mindfulness and Meditation

Chronic stress can take its toll on the body, including releasing cortisol, which suppresses the immune system and can leave you much more susceptible to catching a cold or the flu. Fall is the perfect time to reset, relax and dedicate some time to yourself. Try a meditation app to aid in sleep and relaxation. By using guided meditation solutions to reach deep stages of mindfulness, you can release stress and improve awareness and decision making.

Take a Holistic Approach to Healing

Holistic treatments like red light therapy and lymphatic drainage massages are great ways to give your body a jump start along the healing process, should you come down with a cold or the flu. Red light therapy energizes the entire body from the cellular level, improves blood flow to bring necessary nutrients to the cells and stimulates the lymphatic system, which is one of the key components of a strong immune system. Similarly, lymphatic drainage massages help improve circulation of the lymphatic system by filtering out the toxins in your body to alleviate any swelling or blockages, particularly in the face and neck, that may result from being sick. You can find lots of great DIY tutorials for proper techniques to help yourself or a loved one recover from what’s ailing you with a fun at-home spa day.

During the cold weather season, it can feel like colds, flus and other illnesses are constantly making the rounds within families, classrooms and workplaces. It’s never too early to start building your body’s natural defenses to maintain peak health. Incorporating these simple but effective strategies this cold and flu season will help keep you feeling your best all season long.

2022-10-13T09:01:00

(BPT) – This article is sponsored by Otsuka America Pharmaceutical, Inc. Britney Pridgen, NP, is a paid consultant for Otsuka America Pharmaceutical, Inc.

Attending college is one of the most exciting times in a young adult’s life. During this time, many students begin to experience more independence and learn to navigate the world on their own terms. While exciting, the transition to college life can also present challenges as students acclimate to new surroundings, additional responsibilities, and full accountability for themselves.

For students living with a mental illness, this transition may be challenging during the traditional college years. One U.S. study reported that young adults aged 18-25 years old had the highest prevalence of any mental illness¹, and an additional study reported that dropout rates for students with diagnosed mental health conditions can range from 43% to as high as 86%².

“Many young adults experience an onset of mental illness or an exacerbation of their symptoms around or during their transition to college,” says Britney Pridgen, Psychiatric Nurse Practitioner from Houston Adult Psychiatry. “We also know that mental illness, regardless of age, may impact not only patients, but also families and caregiver support systems. When considered together, the college years can raise the level of concern for students and their families.”

Pridgen says, “Continuity of care is key for people living with a mental illness. Maintaining good habits in managing their condition. Taking medication appropriately, getting enough rest, and finding ways to stay active are all lifestyle habits that can help keep patients healthy and engaged when away at school.”

The transition to college can be challenging for parents who have played an active role in their young adult’s treatment, by monitoring medication or by accompanying them to appointments. Parents may feel less connected their loved one and unsure of their wellbeing while they are away³. However, technology is one way to help young adults living with mental illness, and their parents and support team, be more connected by sharing data even when they are miles apart.

One example of this kind of technology, the ABILIFY MYCITE^® System, helps the patient to capture important data and share it with their health care provider, their care team and even their family members.

ABILIFY MYCITE^® (aripriprazole tablets with sensor) is a prescription medicine of an aripiprazole tablet with an Ingestible Event Marker (IEM) sensor inside it used in adults for the treatment of schizophrenia; treatment of bipolar I disorder alone or when used with the medicine lithium or valproate for acute (short-term) treatment of manic or mixed episodes, or maintenance treatment; and the treatment of major depressive disorder (MDD) along with other antidepressant medicines. The ABILIFY MYCITE System^® is meant to track if you have taken your ABILIFY MYCITE^®. It is not known if ABILIFY MYCITE^® can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole. Please read full INDICATIONS and IMPORTANT SAFETY INFORMATION below, including BOXED WARNING for Increased Risk of Death in Elderly People with Dementia-Related Psychosis and Increased Risk of Suicidal Thoughts or Actions.

The System includes a smart pill and a non-medicated Bluetooth patch that captures and records medication ingestion; a smartphone app that receives the information from the patch and also enables the patient to record other important data like time spent resting and activity level; and a dashboard that the patient can choose to share with their healthcare team and their family members if they choose, to help inform treatment on an ongoing basis.

“I have found the ABILIFY MYCITE System to be useful for some of my patients who are adjusting to a new schedule or need help logging their daily routine, like when they go to college,” says Pridgen. “I’ve also seen how the app can help patients and their family members stay connected by seeing information on their medication ingestion, rest, activity, and mood on a certain day, week, or even over the course of a month. For parents, it can provide greater awareness while supporting the patient during college.”

For more information on the ABILIFY MYCITE System, and to hear from other patients, visit www.abilifymycite.com.

Only functions related to tracking drug ingestion have been evaluated or approved by FDA.

INDICATIONS and IMPORTANT SAFETY INFORMATION for
ABILIFY MYCITE^® (aripiprazole tablets with sensor) 2, 5, 10, 15, 20, 30 mg

INDICATIONS:

ABILIFY MYCITE is a prescription medicine of an aripiprazole tablet with an Ingestible Event Marker (IEM) sensor inside it used in adults for the:

• Treatment of schizophrenia
• Treatment of bipolar I disorder alone or when used with the medicine lithium or valproate for:
• acute (short-term) treatment of manic or mixed episodes
• maintenance treatment
• Treatment of major depressive disorder (MDD) along with other antidepressant medicines

The ABILIFY MYCITE System is intended to track if you have taken your ABILIFY MYCITE. There may be a delay in the detection of the ABILIFY MYCITE tablet and sometimes the detection of the tablet might not happen at all. If the MYCITE APP does not indicate that you have taken your medicine, do not repeat the dose. It is not known if ABILIFY MYCITE can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole. ABILIFY MYCITE is not for use as real-time or emergency monitoring.

IMPORTANT SAFETY INFORMATION:

Do not take ABILIFY MYCITE if you are allergic to aripiprazole or any of the ingredients in ABILIFY MYCITE. Allergic reactions may include: rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue.

ABILIFY MYCITE may cause serious side effects, including:

• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
• Neuroleptic malignant syndrome (NMS), a rare and serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure.
• Uncontrolled body movements (tardive dyskinesia or TD). ABILIFY MYCITE may cause movements that you cannot control in your face, tongue, or other body parts. TD may not go away, even if you stop taking ABILIFY MYCITE. TD may also start after you stop taking ABILIFY MYCITE.
• Problems with your metabolism such as:
  • feel very thirsty
  • need to urinate more than usual
  • feel very hungry
  • feel weak or tired
  • feel sick to your stomach
  • feel confused, or your breath smells fruity
• high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take ABILIFY MYCITE. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before starting ABILIFY MYCITE and during your treatment.
  Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving ABILIFY MYCITE:
• increased fat levels (cholesterol and triglycerides) in your blood.
• weight gain. You and your healthcare provider should check your weight regularly.
• Unusual urges. Some people taking aripiprazole have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Falls
• Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with ABILIFY MYCITE.
• Seizures (convulsions)
• Problems with control of your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with ABILIFY MYCITE. Avoid getting over-heated or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun, and do not wear too much or heavy clothing. Drink plenty of water.
• Difficulty swallowing

ABILIFY MYCITE may make you drowsy. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY MYCITE affects you.

Before taking ABILIFY MYCITE, tell your healthcare provider if you:

• have or had diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before starting and during therapy with ABILIFY MYCITE
• have or had seizures (convulsions)
• have or had low or high blood pressure
• have or had heart problems or stroke
• have or had low white blood cell count
• are pregnant or have plans to become pregnant. It is not known if ABILIFY MYCITE will harm your unborn baby.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ABILIFY MYCITE during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
• are breast-feeding or have plans to breast-feed. ABILIFY MYCITE can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY MYCITE
• have or had any other medical conditions

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ABILIFY MYCITE and other medicines may affect each other causing possible serious side effects. ABILIFY MYCITE may affect the way other medicines work, and other medicines may affect how ABILIFY MYCITE works. Do not start or stop any medicines while taking ABILIFY MYCITE without talking to your healthcare provider first.

The most common side effects of ABILIFY MYCITE in adults include: restlessness or need to move (akathisia); dizziness; nausea; insomnia; shaking (tremor); anxiety; constipation; sedation

These are not all the possible side effects of ABILIFY MYCITE. Call your doctor for medical advice about side effects. You are encouraged to report side effects to Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

©2022 Otsuka America Pharmaceutical, Inc. All rights reserved.

AUGUST 2022 12US22EBC0022

References

1. Mental Illness, N. I. of. (2022, January). Mental illness. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/mental-illness 2. Sciences, C. N. A. of. (2021, January 13). Mental health, substance use, and wellbeing in Higher Education: Supporting the whole student. The National Academies Press. https://nap.nationalacademies.org/catalog/26015/mental-health-substance-use-and-wellbeing-in-higher-education-supporting 3. Dorrance Hall, E. (2018). The challenges of parenting while in college. Psychology Today. https://www.psychologytoday.com/us/blog/conscious-communication/201806/the-challenges-parenting-while-in-college

2022-10-14T15:51:00

(BPT) – David was in his thirties and living a healthy life when doctors discovered a cancerous mass in his neck. He began treatment immediately, unsure about the journey ahead, and after enduring several therapies that left him feeling worse, his thyroid cancer was still spreading. Luckily, through a support group, David’s wife Kathleen discovered that he could have his tumor tested to see if it had a specific genetic alteration.

GAVRETO may affect fertility in males and females, which may affect a patient’s ability to have children. Patients should talk to their healthcare provider if this is a concern for them.

These are not all of the possible side effects of Gavreto. Patients should call their doctor for medical advice about side effects. Patients are encouraged to report side effects to the FDA. Visit FDA MedWatch or call 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for Gavreto.

This content was developed by Blueprint Medicines Corporation and Genentech, Inc.

References:

1. American Cancer Society: Cancer Action Network. (2020, September). Survivor Views: Biomarker Testing. American Cancer Society.
2. Kris, M. G. et al (2014). Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs. JAMA, 311(19). https://doi.org/10.1001/jama.2014.3741.

M-US-00014101v(1.0)

2022-10-18T11:37:01

(BPT) – Nearly 2,000 U.S. HCPs Have Prescribed RADICAVA^® (edaravone) and RADICAVA ORS Since the Products Became Available in August 2017 and June 2022

RADICAVA and RADICAVA ORS Have Been Used to Treat 8,000 Patients with Over 1.1 Million Days of Therapy

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that nearly 2,000 people with amyotrophic lateral sclerosis (ALS) have received RADICAVA ORS^® (edaravone).¹ Since RADICAVA^® (edaravone) and RADICAVA ORS became available in the U.S. in August 2017 and June 2022, respectively, nearly 2,000 U.S. healthcare providers (HCPs) have prescribed the therapies to one or more of their patients.²

RADICAVA ORS is an oral formulation that offers the same efficacy as RADICAVA, an intravenous (IV) treatment that was shown in a pivotal trial to help slow the loss of physical function in ALS.^3,4 RADICAVA and RADICAVA ORS have been used to treat 8,000 patients in the U.S. with over 1.1 million days of therapy.⁵

“Our driving focus at MTPA is to ensure we’re making a meaningful difference in the lives of people living with ALS, and this milestone exemplifies our commitment to this goal,” said Atsushi Fujimoto, President, MTPA. “We are pleased by the amount of ALS patients that have received RADICAVA ORS over the past few months, including new patients as well as those who have switched from RADICAVA, and we look forward to seeing this number rise as more patients gain access to this new oral treatment option.”

“ALS affects patients in varying ways, which means their treatment needs are continuously evolving,” said Terry Heiman-Patterson, M.D., Professor, Neurology, Lewis Katz School of Medicine at Temple University, Director, Temple MDA/ALS Center of Hope. “RADICAVA ORS offers patients the flexibility of an alternate delivery option, and I am eager to continue to see this medication reach more people in the coming years.”

In clinical trials, the most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%).³ In an open-label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.³ RADICAVA and RADICAVA ORS are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients. See Important Safety Information below.

RADICAVA ORS is approved as a 5 mL dose that can be taken orally or via feeding tube, providing a portable and flexible administration option to ALS patients, with no infusion required. With appropriate instruction from a HCP, RADICAVA ORS may take only a few minutes to administer on treatment days.³ RADICAVA ORS should be taken in the morning after overnight fasting for eight hours.³ To learn more about RADICAVA ORS, visit RADICAVA.com.

As a part of MTPA’s commitment to helping people with ALS access RADICAVA and RADICAVA ORS, MTPA created the JourneyMate Support Program™, which provides educational resources to help patients and caregivers on their ALS treatment journey.

The JourneyMate Support Program™ helps to give patients understanding, answers, and resources to supplement what their doctor provides. Experienced program team members are trained to address patient educational needs and provide them with personalized answers and resources for living with ALS. For more information, call 1-866-684-7737 or visit RADICAVA.com/journeymate.

An estimated 5,000-6,000 Americans are diagnosed each year with ALS, a neurodegenerative disease that currently has no cure and can progress rapidly, as well as lead to muscle weakness and eventual loss of function.^6-8 The majority of ALS patients succumb to the disease within two to five years of receiving a diagnosis, but progression of the disease can vary significantly.^7,8

About RADICAVA^® (edaravone) and RADICAVA ORS^® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA^® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS^® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA is administered in 28-day cycles by IV infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.³

Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, RADICAVA was approved for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), China (July 2019), Indonesia (July 2020), Thailand (April 2021) and Malaysia (December 2021).To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 8,000 patients, with over 1.1 million days of therapy, and have been prescribed by nearly 2,000 HCPs.^1,2

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.

Adverse Reactions
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

For more information, including full Prescribing Information, please visit www.RADICAVA.com.

About JourneyMate Support Program™
The JourneyMate Support Program™ offers educational support and resources for patients who are considering or have already been prescribed an MTPA product. An ALS Clinical Educator is an educational resource for patients who have been prescribed a Mitsubishi Tanabe Pharma America, Inc. (MTPA) product. An ALS Clinical Educator is provided by MTPA and VMS and is not affiliated with or provided by a doctor. An ALS Clinical Educator does not provide medical advice. The program does not provide medical advice and does not take the place of a patient’s doctor. All questions about a condition, diagnosis, or treatment should be referred to the patient’s doctor. If a patient has a medical emergency, they should call 911. Adverse events or product complaints should be reported by calling 1-888-292-0058.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

About Mitsubishi Tanabe Pharma Development America, Inc.
The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s 100 percent-owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. For more information, please visit https://mt-pharma-development-america.com/.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of the Mitsubishi Chemical Group, is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. The Mitsubishi Chemical Group has positioned health care as its strategic focus in its management policy, “Forging the future”. MTPC sets the MISSION of “Creating hope for all facing illness”. To that end, MTPC is prioritizing work on “precision medicine” to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.

Media inquiries:
Media_MTPA@mt-pharma-us.com

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¹ Data on file. Mitsubishi Tanabe Pharma America, Inc.
² Data on file. Mitsubishi Tanabe Pharma America, Inc.
³ RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
⁴ Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512.
⁵ Data on file. Mitsubishi Tanabe Pharma America, Inc.
⁶ Marin B, Boumediene F, Logroscino G, et al. (2016). Variation in worldwide incidence of amyotrophic lateral sclerosis: a metaanalysis. Int J Epidemiol, 00:1-18.
⁷ ALS Association. Facts You Should Know About ALS. http://web.alsa.org/site/PageServer?pagename=ALSA_Facts. Accessed July 2022.
⁸ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health, June 2013, https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet. Accessed July 2022.

2022-10-21T09:01:00

(BPT) – For the more than 643 million people worldwide with type 2 diabetes, the disease’s health-related issues can be serious, deadly, and costly. Diet and exercise can help control diabetes. But a recent study shows that the remission of type 2 diabetes is achieved more effectively and with longer-lasting results with bariatric surgery, rather than through medications and lifestyle changes.

Reversing a diagnosis of life-altering diabetes is empowering. April Ammons of Florida (a patient of bariatric surgeon Michael Baptista, M.D. of Jacksonville) was diagnosed with type 2 diabetes on her 40th birthday. She progressed from oral diabetes medication to an insulin pump combined with oral medications and insulin injections. But today, she says she has been released from “diabetic prison” thanks to the 110 pounds she lost after having an adjustable gastric band (AGB) surgically placed.

“The band made it possible for me to discontinue use of the insulin pump, and as the weight came off, the diabetic medications decreased,” says April. “I would never dream that I would be free of the horrible effects of diabetes — pain when walking, sleeping with a CPAP machine, depression, overall exhaustion. My A1C was once in the 15s and is now in the 7s. To say my doctor is thrilled is an understatement.”

Backed by 25 years of clinical evidence, the FDA-approved Lap-Band^® system features an AGB placed around the upper stomach to help limit food intake and promote a feeling of fullness. It involves a short, outpatient procedure and brings power over hunger and more control because of its adjustability over weight loss than other bariatric surgery options. On average, patients kept off 60% of their excess body weight after five years of having the minimally invasive Lap-Band surgery¹.

Lap-Band can be a powerful option for those with diabetes. In fact, of people with diabetes who had a Lap-Band placed, 73% reported remission of type 2 diabetes due to weight loss after two years².

The Lap-Band system is for those with a body mass index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions, like diabetes. The band can be tightened or loosened as a patient’s body or physical needs change over time, helping to provide sustainable weight loss over the long term. Regular adjustments by a surgeon help continue weight loss. Think about it like having to tighten your belt as the weight comes off.

April, who had her Lap-Band surgery in 2021, now takes line dancing, stretching, and yoga classes at a gym. She’s enjoying going to the beach and traveling again.

“For me, my new life began after the 45-minute procedure to place the band and a couple of days of recuperation,” says April. “I’m in awe of the changes I have experienced since my surgery, and I finally feel like I am an active participant in my life again. I encourage any diabetic battling weight issues to talk to your surgeon about the procedure.”

Visit Lap-Band.com to find a Lap-Band surgeon near you.

Actual patient. The views and opinions expressed here are patient’s own. Patients’ experience and results may vary.

Important Safety Information

Patients’ results and experiences may vary. The LAP-BAND^® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions. It is indicated for use only in adult patients who have failed more conservative weight-reduction alternatives. This surgery requires significant changes in eating habits. This system is contraindicated in non-adult patients (patients under 18 years of age) with inflammatory diseases of the gastrointestinal tract, severe cardiopulmonary diseases, esophageal or gastric varices, portal hypertension, or who currently are or may be pregnant. Placement of the system is major surgery and, therefore, death can occur. Most common related adverse events include: band slippage, pouch dilatation, stoma obstruction, gastroesophageal reflux, esophageal dilation, cholelithiasis, incisional infection, abdominal pain, gastroenteritis, or nausea and vomiting.

For full safety information: https://www.lapband.com/safety/. CAUTION: Rx only

¹ Ray James, Ray Shahla. Surgery for Obesity and Related Diseases. Safety, efficacy, and durability of laparoscopic adjustable gastric banding in a single surgeon U.S. community practice

² Dixon, John et al. JAMA Vol 299 No 3 Jan 2008 Adjustable Gastric Banding and Conventional Therapy for Type 2 Diabetes: A Randomized Controlled Trial