Oral Edaravone Under FDA Priority Review, Decision Expected in May

Oral Edaravone Under FDA Priority Review, Decision Expected in May

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Oral Edaravone Under FDA Priority Review, Decision Expected in May

A decision is expected by May from the U.S. Food and Drug Administration (FDA) on an application seeking approval of an oral formulation of edaravone (MT-1186) — one with a similar clinical profile to Radicava — as a treatment for amyotrophic lateral sclerosis (ALS). The FDA is now reviewing that application, from Mitsubishi Tanabe Pharma America (MTPA), and has given it priority review, a designation granted to therapies with the potential to markedly improve care…

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