Mitsubishi Tanabe files for US approval of edaravone

20 June 2016

Mitsubishi Tanabe Pharma (TYO: 4508) today revealed that a New Drug Application has been submitted to the US Food and Drug Administration for edaravone (MCI-186) for the treatment of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurological disease.

The news pushed the Japanese pharma major shares up 1.8% to 1,813 yen. As many as 30,000 Americans may be affected by ALS with more than 5,600 diagnosed annually. There is currently no cure.

This submission is the company's first step in accelerating its US business development activities as part of its "Medium-Term Management Plan 16-20: Open up the Future." As part of this plan, the company established MT Pharma America Inc to commercialize approved pharmaceutical products in the USA with plans to expand its product line through collaborations with partners.

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