Mitsubishi Tanabe Pharma America Presents Real-World Data on RADICAVA® (edaravone) at 2022 American Academy of Neurology Annual Meeting

Analysis Suggests Use of RADICAVA IV is Associated with Improved Survival in People with ALS

JERSEY CITY, N.J., April 4, 2022  /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of an analysis of real-world data that suggest continued treatment of amyotrophic lateral sclerosis (ALS) patients with intravenous (IV) RADICAVA^® (edaravone) resulted in a six-month longer median survival, compared to those not treated with the drug. The findings were presented as part of the 2022 American Academy of Neurology (AAN) Annual Meeting, being held in Seattle, Wash., from April 2-7.

"Real-world data may provide additional insight into treatment for rare diseases like ALS, which can sometimes be challenging to research and evaluate in clinical trials," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "Findings from this analysis, combined with previously reported pivotal Phase 3 trial data, add to the growing body of knowledge regarding the use of RADICAVA."

The analysis utilized Optum's Clinformatics^® Data Mart (CDM), a real-world de-identified database of administrative health claims across the U.S. for members with commercial or Medicare Advantage health plans, to evaluate data on overall survival among ALS patients who were treated with RADICAVA IV for at least 12 months, compared to a control group of patients not prescribed the product. Implementing 1:1 propensity score matching, the analysis compared 318 non-RADICAVA IV-treated control patients with 318 patients who initiated RADICAVA IV treatment between August 8, 2017, and March 31, 2020.

"Utilizing rigorous statistical methodology to assess nearly four years of administrative claims data, we found that patients with ALS receiving RADICAVA IV survived longer than patients not treated with the drug in a real-world setting," said Benjamin Rix Brooks, M.D., an ALS specialist and lead author of the study. "The results from this analysis are encouraging and we are hopeful that the continued examination of real-world data, alongside randomized clinical trial results, will help guide research into new therapies and optimize treatment selection for patients with ALS."

Results from the analysis showed:

• RADICAVA IV was associated with a six-month longer median survival compared with the non-RADICAVA IV-treated patients when treated for at least 12 months.
• Median survival was 29.5 months (95% CI, 25.4-35.9) for the RADICAVA IV-treated patients and 23.5 months (95% CI, 20.0-28.0) for the non-RADICAVA IV-treated patients.
• The risk of death during the study was 27% lower for the RADICAVA IV-treated patients than for non-RADICAVA IV-treated patients (hazard ratio [HR], 0.73; 95% CI, 0.59–0.91; P=.005).
• Between August 8, 2017, and March 31, 2021, 155 all-cause deaths (48.7%) were reported among RADICAVA IV-treated patients vs. 196 (61.6%) among the non-RADICAVA IV-treated patients.

The findings from these data provide important insights, and the company will continue to explore real-world experience through additional research.

It is important to note that real-world data studies ordinarily cannot determine definitive causal conclusions about the effects of treatment.¹ Understanding the utility and limitations of real-world data is critical to proper application of insights.²

This analysis was funded and conducted by MTPA.

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).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. The 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 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).

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.

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), founded in 1678, is one of the oldest pharmaceutical companies in the world. Focused on ethical pharmaceuticals, MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. In light of the anticipated changes in healthcare needs in the future, MTPC is advancing business activities under the mission of "Creating hope for all facing illness," and has set the corporate vision for 2030 (VISION 30) to "Be a healthcare company that delivers optimal therapy to each individual." As part of the vision for 2030, MTPC is prioritizing work on "precision medicine" to create effective therapies and preventive methods 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. MTPC is a member of Mitsubishi Chemical Holdings Group. For more information, go to https://www.mt-pharma.co.jp/e/.

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¹Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. Pharmacoepidemiol Drug Saf. 2017;26(9):1033-1039.

²U.S. Food and Drug Administration. Framework for FDA's Real-World Evidence Program. Accessed March 2022. https://www.fda.gov/media/120060/download.

³RADICAVA^® (edaravone) U.S. Prescribing Information. March 2021.

SOURCE Mitsubishi Tanabe Pharma America, Inc.