JERSEY CITY, N.J., May 12, 2021 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced it will present findings from a new analysis of claims data from a cohort of patients who received RADICAVA® (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS). The analysis will be presented during the 2021 European Network to Cure ALS (ENCALS) Meeting, being held virtually May 12-14.
“Initial insights shared with the scientific community during ENCALS are a part of our wide-ranging efforts to compile real-world data that can be used to learn as much as possible about the clinical experience of RADICAVA,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. “We utilized a rigorous statistical methodology to comprehensively assess more than two years of administrative claims data for our therapy. Analysis is still ongoing, and we look forward to sharing more details about the methodology and findings with the ALS scientific community.”
The analysis, funded and conducted by MTPA, utilized a real-world de-identified database of administrative health claims across the U.S. to evaluate data on overall survival among commercially insured ALS patients treated with RADICAVA, compared to a control group of patients not prescribed the product. Utilizing 1:2 propensity score matching, the analysis compared 635 non-RADICAVA-treated control patients with 319 patients who initiated RADICAVA treatment between August 8, 2017 and June 30, 2019.
Details about the findings will be shared at ENCALS. MTPA will be conducting further analysis of this real-world data with plans to submit the full results for publication in a peer-reviewed journal. While a randomized controlled clinical trial evaluating overall survival has not been conducted, the findings from this data provide important insights. The company also will continue to explore real-world experience through additional research.
About RADICAVA® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) 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 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.
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.
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/.
- RADICAVA® (edaravone) U.S. Prescribing Information. March 2021.
- Research by TOKYO SHOKO RESEARCH, LTD.