Alzheimer’s drug heads to FDA for approval

Biogen has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimer’s disease, according to a company press release.

The submission included data from the Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1b PRIME study.

In March 2019, the EMERGE and ENGAGE trials were discontinued after a futility analysis indicated that the studies were unlikely to meet the primary endpoint. In October 2019, the company said a review of data showed that aducanumab reduced cognitive decline in EMERGE.

The FDA now has up to 60 days to decide whether to accept the application for review.

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