Japan's Mitsubishi Tanabe files for ALS drug edaravone in U.S.

FDA sign
FDA sign

Osaka-based Mitsubishi Tanabe Pharma has moved to get U.S. FDA approval for edaravone (Radicut) to treat amyotrophic lateral sclerosis (ALS) as it moves to expand its product offerings in the key market through collaboration with partners and new a local unit.

In a release, the company said as many as 30,000 people in the U.S. suffer from the progressive neurological condition known as Lou Gehrig's disease after a famous baseball player, with an estimated 5,600 diagnosed each year.

MT Pharma America was started earlier this year as a marketing arm in the U.S. with a target date for approval in 2017 for approval of the ALS candidate.

U.S. approval for edaravone (MCI-186) would draw on clinical data from Japan where the drug marketed as Radicut was launched around a year earlier to treat ALS patients and has been used since 2001 to treat acute cerebral infarction.

Phase III results of a study on 137 Japanese patients were presented at the American Academy of Neurology meeting in April and demonstrated less functional motor-control loss, compared to standard of care, meeting its primary endpoint.

"There is an urgent need for new treatment approaches that may affect the course of this devastating disorder," Lucie Bruijin, chief scientist of the ALS Association, said in a statement.

- here's the release

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Mitsubishi Tanabe says ALS drug meets PhIII endpoint

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