FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Accepts Alder’s Migraine Biologic for Review

May 1, 2019

The FDA agreed to review Alder BioPharmaceuticals’ biologics license application for eptinezumab for prevention of migraine, the Bothell, Washington-based company said.

Alder has high hopes for the IV-delivered monoclonal antibody, the company’s lead commercial candidate. Alder filed its BLA in February and the agency accepted it for review this week.

The company reported positive results from two Phase III trials to support eptinezumab’s safety and effectiveness. It’s hoping for agency approval in the fall and a commercial launch early next year.

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