Today, the FDA accepted the New Drug Application submitted by Mitsubishi Tanabe Pharma Corporation for edaravone (MCI-186, Radicut®), a proposed treatment of ALS. In June 2015, the company was awarded approval of marketing edaravone from the Pharmaceutical and Medical Device Agency (PMDA) in Japan as a treatment for ALS. The antioxidant compound is marketed as Radicut in that country. The FDA is expected to make a decision on the application by the end of June 2017, according to a press release from the company. If approved by the FDA, edaravone will be marketed in the United States as Radicava by the company's subsidiary MT Pharma America, Inc.
"This is an important step forward for edaravone and we look forward to hearing the final decision by the FDA less than a year from now. The people with ALS that participated in the many clinical trials of this drug, together with the scientists and clinicians at Mitsubishi Tanabe in Japan and at MT Pharma America, should be recognized for this achievement," said Steve Perrin, Ph.D. CEO & CSO of the ALS Therapy Development Institute.
The announcement today states that the FDA has accepted a New Drug Application (NDA) for edaravone. This doesn't mean that the drug is approved by the FDA yet, however it is an important step forward towards achieving that goal. The FDA typically takes between 6 and 12 months to review an application, depending on whether or not the FDA awards priority review to a NDA submission. If approved by the FDA, Radicava would be the first such approval of a treatment for ALS in the United States in more than two decades. Two other compounds could move toward potential NDA filing at the FDA for ALS over the next year, including Cytokinetics' tirasemtiv and AB Science's masitinib.
- Read more about Radicut® and Approval in Japan
- Mitsubishi Tanabe Pharma Press Release
- August 2016 Webinar on edaravone coming to US