Mitsubishi Tanabe Pharma America Presents Analysis Examining Real-World Data on ALS Patient Disease Progression Milestones

JERSEY CITY, N.J., April 20, 2021 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of an analysis of the timing of disease progression milestones among commercially insured amyotrophic lateral sclerosis (ALS) patients treated with intravenous (IV) RADICAVA^® (edaravone). The findings are being presented during the 2021 Virtual American Academy of Neurology (AAN) Annual Meeting, held April 17-22.

"We are pleased to share these data, which may provide information to the ALS community by observing the time to real-world milestones associated with ALS progression," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "The results from this new analysis of real-world data gives clinicians more information that may be useful in evaluating treatment for their patients."

The analysis utilized a completely de-identified database of administrative health claims across the U.S. to evaluate 117 commercially insured patients who initiated treatment with IV RADICAVA (between August 2017 and June 2019, index date), and had at least six months of continuous pre- and 12 months post-index enrollment in the database. Milestones, including the use of canes, walkers and wheelchairs, artificial nutrition, noninvasive ventilation, invasive ventilation/speech-generating devices and hospice, were defined according to the Healthcare Common Procedure Coding System, a standardized coding system.

This analysis was funded and conducted by MTPA. The poster will be available during and for 30 days following the 2021 Virtual AAN Annual Meeting.

About RADICAVA^® (edaravone) IV

The U.S. Food and Drug Administration (FDA) approved RADICAVA^® (edaravone) IV on May 5, 2017 as a treatment for amyotrophic lateral sclerosis (ALS).¹ 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 IV 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.

INDICATION

RADICAVA is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

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.

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.

Overview of Mitsubishi Tanabe Pharma Corporation
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 with one of the longest histories of pharmaceutical companies in Japan.² Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas — immune-inflammation diseases, central nervous system, and vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA. For more information, go to https://www.mt-pharma.co.jp/e/.

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Debbie Etchison
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¹ RADICAVA^® (edaravone) U.S. Prescribing Information. March 2021.
² Research by TOKYO SHOKO RESEARCH, LTD.

SOURCE Mitsubishi Tanabe Pharma America, Inc.