Mitsubishi Tanabe Pharma Corporation Gains Approval of Radicut for ALS in Japan

Mitsubishi Tanabe Pharma Corporation has received approval from the Japanese regulatory agency, the Pharmaceutical and Medical Device Agency (PMDA), to market Radicut for treatment of ALS in Japan. Radicut, also known as Edaravone or MCI-186, is a free radical scavenger discovered by MTPC that is also marketed for treatment of the acute phase of cerebral infarction, a type of ischemic stroke. The company reports that a series of clinical trials in ALS patients show reduced functional loss with Radicut treatment as compared to placebo. The company has not yet applied for drug approval in the U.S., however, it was granted Orphan Drug Designation for Radicut from the FDA in 2015. Interestingly, earlier this year Treeway also gained Orphan Drug Designation in the U.S. for their reformulated version of Radicut, called TW001 (see March 2015 news).

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disease-als radicut topic-clinical
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