MTLHF - Mitsubishi Tanabe wins FDA approval for oral form of ALS drug

Japanese pharma company, Mitsubishi Tanabe Pharma Corporation (OTCPK:MTZPY) announced on Friday that the FDA approved Radicava ORS (edaravone), ab oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS). Radicava ORS delivers the same active ingredient as the company’s intravenous ALS therapy, Radicava, which was approved by the FDA in 2017. Radicava ORS is designed for self-administration and can be taken at home with a similar dosing regimen to Radicava. The FDA approval was based on data indicating comparable levels of Radicava ORS to the levels from Radicava IV infusion in the blood following administration. Mitsubishi Tanabe Pharma Corporation (OTCPK:MTZPY) is a member of Mitsubishi Chemical Holdings Group (OTCPK:MTLHY) (OTCPK:MTLHF). Read: In March, an expert panel of the FDA voted against granting the approval for Amylyx Pharmaceuticals (AMLX) for its experimental ALS therapy, AMX0035.

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Mitsubishi Tanabe wins FDA approval for oral form of ALS drug