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FDA Accepts Amgen’s Aimovig Application

By staff-author

July 20, 2017

16

Amgen Inc. on Thursday announced that the U.S. Food and Drug Administration has accepted the biologics license application for Aimovig, a drug for prevention of migraine. Biologics license application is a request for permission to introduce the drug to interstate commerce. The application can only be submitted after the company has completed clinical studies and finalized the labeling requirements. If the application is approved, the Thousand Oaks biotech will jointly commercialize the drug in the U.S. with Novartis, a pharmaceutical company based in Switzerland. Amgen and Novartis are currently in collaboration to develop treatments in the field of migraine and Alzheimer’s disease. “Migraine is a serious neurological disease that has a substantial economic burden for both patients and the health care system, yet it continues to be under recognized and under treated,” Sean E. Harper, vice president of research and development at Amgen, said in a statement. “We are pleased to advance Aimovig, to help address the unmet need in this community and potentially mitigate the overall burden of this disease for patients who have already tried other therapeutic options.” News of the application was announced Thursday afternoon after the market closed. Shares of Amgen (AMGN) closed up 14 cents, or a fraction of a percent, to $179.32 on the Nasdaq.

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