Mitsubishi Tanabe Pharma America Announces Enrollment Has Resumed for the Global Phase 3 Study of Oral Edaravone for ALS
JERSEY CITY, N.J., August 24, 2020 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that the global Phase 3 study to evaluate the long-term safety and tolerability of an investigational oral suspension formulation of edaravone (MT-1186) in patients with amyotrophic lateral sclerosis (ALS) has resumed screening and enrollment. The trial, sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), was initiated in November 2019 and some clinical trial operations were temporarily paused in March 2020 due to the COVID-19 pandemic.
“MTDA is taking a thoughtful, cautious approach to resuming this study, including working closely with the investigator sites to implement appropriate COVID-19 protocols,” said Atsushi Fujimoto, President, MTPA. “We are extremely pleased to be able to announce that the study has resumed enrollment.”
The global, multi-center, open-label study will evaluate up to 150 people with ALS across an estimated 65 sites in the U.S., Canada, Europe and Japan over the course of 48 weeks of treatment. Approximately half the study sites will be located in the U.S. After a screening period of up to 21 days, study participants (18 to 75 years of age) will receive oral edaravone according to the same FDA-approved dosing regimens as the IV formulation of RADICAVA® (edaravone).
Patients interested in being screened for the trial can call 800-313-9381 or visit ClinicalTrials.gov (NCT04165824) for more information.
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/.
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 and MTDA. For more information, go to http://www.mt-pharma.co.jp/.
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.
1 Research by TOKYO SHOKO RESEARCH, LTD.
2 RADICAVA® U.S. Prescribing Information. August 2018.