Biogen’s FDA application for Alzheimer’s drug drags on

Korea Biomedical Review

15 June 2020 - Biogen’s filing of aducanumab, an investigational Alzheimer’s drug, for U.S. approval is drifting from its initial goal.

The company had planned to seek the license early this year, but it recently said it would start discussing the FDA filing in the third quarter. The delay prompted some skeptics to doubt aducanumab’s efficacy.

In a regular meeting with shareholders on 3 June, Biogen said it would seek the nod, not only in the U.S. but Europe and Japan simultaneously, in the third quarter.

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Michael Wonder

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Michael Wonder

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Medicine , Timelines , Dossier