Post-Hoc Analysis of Phase 3 Study Examines Effect of Early Intervention with Edaravone on Survival and Disease Progression Milestone Events in ALS Patients

JERSEY CITY, N.J., March 18, 2021 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced a post-hoc analysis of its Phase 3 edaravone study reviewing the results of intravenous (IV) edaravone treatment on disease progression milestones and events among people with amyotrophic lateral sclerosis (ALS). In the analysis, a risk reduction was observed for the exploratory composite estimate of time to death, tracheostomy, permanent assisted ventilation (PAV), and hospitalization. The data was highlighted as an oral presentation at the 2021 Muscular Dystrophy Association Clinical & Scientific Virtual Conference.

"While the Phase 3 edaravone study was not designed with survival as an endpoint, this post-hoc analysis allows us to explore insights on the results of early treatment intervention on survival-related events due to ALS progression, including death, hospitalization, ventilation and tracheostomy," said Atsushi Fujimoto, President, MTPA. "We are committed to putting patients first in everything we do, which includes working to explore our Phase 3 data in order to help expand understanding."

This post-hoc analysis assessed the double-blind, placebo-controlled 24-week Phase 3 study of edaravone, including an additional 24-week open-label period with all patients receiving IV edaravone (i.e., edaravone-edaravone [EE] vs. placebo-edaravone [PE] groups). There were no deaths during the double-blind period. During the open-label period, there were two deaths in the EE group and four in the PE group. Survival analysis of the cumulative occurrence of milestone events (death, tracheostomy, PAV and hospitalization due to ALS progression) showed a 53 percent relative risk reduction in the EE group, with a hazard ratio of 0.47. The hazard ratio for death alone was 0.48 for the EE group vs. the PE group. As these results are from a post-hoc analysis, the results should be interpreted with caution and cannot be considered conclusive evidence of efficacy.

"I'm encouraged by the findings of this post-hoc analysis," said Benjamin Rix Brooks, M.D., an ALS specialist and lead author of the study. "We were able to uncover data that reinforces the need to further our research that can show an important association between edaravone use and the potential decrease in functional decline."

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).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/.

Important Disclosure
Dr. Brooks has provided consulting services for MTPA.

Media Inquiries:
Debbie Etchison
908-340-8578
[email protected] 

¹ RADICAVA^® (edaravone) U.S. Prescribing Information. August 2018.
² Research by TOKYO SHOKO RESEARCH, LTD.

SOURCE Mitsubishi Tanabe Pharma America, Inc.