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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