Mitsubishi Tanabe Pharma America Marks Third Anniversary Of FDA Approval And Reports More Than 5,000 Patients With ALS Treated With RADICAVA® (edaravone)

JERSEY CITY, N.J., May 5, 2020 /PRNewswire/ --Mitsubishi Tanabe Pharma Corporation. (MTPA) today reported that more than 5,000 people with amyotrophic lateral sclerosis (ALS) have received the treatment with RADICAVA^® (edaravone) in North America since the therapy was approved by the U.S. Food and Drug Administration (FDA) on May 5, 2017.

“These are unprecedented times with the world facing the COVID-19 pandemic, and we continue to dedicate ourselves each day to doing what we can to support people with ALS and their families,” said Atsushi Fujimoto, President, MTPA. “Although we want to acknowledge the significance of this third anniversary, our thoughts and efforts are focused on meeting the needs of the patient community. We salute the tireless dedication of the many heroes in the ALS community who are making a difference during the pandemic. We at MTPA are honored to be a part of the medical community making a difference in patients’ lives.”

An estimated 5,000-6,000 Americans are diagnosed each year with ALS, a rapidly progressive neurodegenerative disease that affects the nerve cells in the brain and the spinal cord.^1,2,3 The majority of ALS patients die within two to five years of receiving a diagnosis, but progression of the disease can vary significantly.⁴

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. MTPA is dedicated to delivering innovative products that address the unmet medical needs of patients in North America. It was established by MTPC to commercialize approved pharmaceutical products in North America with plans to expand its product line through collaborations with partners. For more information, please visit www.mt-pharma-america.com or follow us on Twitter and Facebook.

Overview of Mitsubishi Tanabe Pharma Corporation (MTPC)
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan’s pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company and has the longest history of any listed company in Japan. In accordance with the corporate philosophy of “contributing to the healthier lives of people around the world through the creation of pharmaceuticals,” the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 2016-2020. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas — autoimmune diseases, diabetes and kidney diseases, central nervous system diseases, and vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA and the license holder of RADICAVA. For more information, go to http://www.mt-pharma.co.jp/.

About RADICAVA^® (edaravone)
The U.S. Food and Drug Administration approved RADICAVA^® (edaravone) on May 5, 2017, as a treatment for amyotrophic lateral sclerosis (ALS).⁵ In a pivotal trial, people given RADICAVA experienced a 33 percent slower rate of decline in the loss of physical function, compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in people with ALS.^6,7 Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. Marketing authorization was granted in Canada in October 2018 and Switzerland in January 2019.

IMPORTANT SAFETY INFORMATION
Before you receive RADICAVA, tell your healthcare provider about all of your medical conditions, including if you:

• have asthma.
• are allergic to other medicines.
• are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breast milk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of RADICAVA?

• RADICAVA may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
• Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.
• RADICAVA contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
• Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
• Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.

The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.

These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Media inquiries:
Debbie Etchison
908-340-8578
Media_MTPA@mt-pharma-us.com

1. Centers for Disease Control and Prevention – National Amyotrophic Lateral Sclerosis (ALS) Registry (April 25, 2017).
2. Frequently Asked Questions – Questions About ALS. Retrieved from https://www.cdc.gov/als/ALSFAQ.html.
3. Marin B, Boumediene F, Logroscino G, et al. (2016). Variation in worldwide incidence of amyotrophic lateral sclerosis: a meta-analysis. Int J Epidemiol, 00:1-18.
4. National Institute of Neurological Disorders and Stroke. Amyotrophic Lateral Sclerosis (ALS) Information Page. https://www.ninds.nih.gov/disorders/all-disorders/amyotrophic-lateral-sclerosis-als-information-page. Accessed April 2020.
5. Research by TOKYO SHOKO RESEARCH, LTD.
6. RADICAVA® U.S. Prescribing Information. August 2018.
7. Simon, N. G., Turner, M. R., Vucic, S., Al-Chalabi, A., Shefner, J., Lomen-Hoerth, C., & Kiernan, M. C. (2014). Quantifying Disease Progression in Amyotrophic Lateral Sclerosis. Annals of Neurology, 76(5), 643–657.http://dx.doi.org/10.1002/ana.24273

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SOURCE Mitsubishi Tanabe Pharma America, Inc.