JERSEY CITY, N.J., November 9, 2020 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that patient enrollment has been completed for the global Phase 3 open-label study evaluating the long-term safety and tolerability of an investigational oral suspension formulation of edaravone (MT-1186) in patients with amyotrophic lateral sclerosis (ALS). The study is sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA).
“Mitsubishi Tanabe Pharma group companies are committed to the fight against ALS, and reaching this milestone is a demonstration of our dedication to supporting the ALS community,” said Atsushi Fujimoto, President, MTPA. “We are grateful to the participants, the investigators and the clinical staff at the study sites as well as the MTDA staff working on this study. With this oral edaravone Phase 3 study now fully enrolled, we are one step closer to reaching our goal of having an additional treatment option for patients.”
The global multi-center, open-label study (MT-1186-A01), is evaluating approximately 185 ALS patients across approximately 50 sites in the U.S., Canada, Europe and Japan over the course of 48 weeks of treatment. After a screening, study participants (18 to 75 years of age) receive oral edaravone at a dose designed to deliver the therapeutic equivalent of the IV formulation of RADICAVA® (edaravone) approved by the U.S. Food and Drug Administration in 2017.
“ALS is a devastating, debilitating disease, and I am very pleased to be involved in this important research,” said Angela Genge, M.D., FRCP (c), Executive Director, Clinical Research Unit, and Director, ALS Clinic, Montreal Neurological Institute-Hospital, who is a principal investigator for North America. “The completion of enrollment for the study is a crucial step in our efforts to explore potential treatment options for these patients.”
MT-1186 is an investigational oral formulation of edaravone being studied in patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed by researchers together with Mitsubishi Tanabe Pharma Corporation (MTPC), headquartered in Osaka, Japan. In May 2019, MTP group companies completed a series of Phase 1 studies administering the oral suspension and intravenous formulations of edaravone in healthy volunteers. In addition to the current MT-1186-A01 Phase 3 study, MTDA also has other oral edaravone studies in development, including an extension study, MT-1186-A03, to explore patient safety after 96 weeks of edaravone administration. More information is available at ClinicalTrials.gov (NCT04165824 and NCT04577404).
Postmarketing Commitment Study
An additional study, MT-1186-A02, which is a postmarketing commitment for the IV RADICAVA product, also will explore daily dosing of oral edaravone in ALS patients. MT-1186-A02 is not planned to be included with the initial New Drug Application (NDA) submission for orally administered edaravone. More information is available at ClinicalTrials.gov (NCT04569084).
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. MTDA is dedicated to research and develop innovative pharmaceutical products that address the unmet medical needs of patients. For more information, please visit https://mt-pharma-development-america.com/.
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.1 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 — immune-inflammation diseases, diabetes and kidney, 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/.
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).2 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.
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.
- Research by TOKYO SHOKO RESEARCH, LTD.
- RADICAVA® U.S. Prescribing Information. August 2018.