FDA Advisory Committee Votes in Favor of Eisai, Biogen’s Leqembi

An advisory committee for the US Food and Drug Administration (FDA) voted 6-0 in favor of full approval for Leqembi, Eisai and Biogen’s treatment for Alzheimer’s disease. The decision was made based on results from the Clarity AD study, which the committee members believed strongly supported its clinical benefits for patients.

According to Eric Sagonowsky, “Leqembi won an accelerated FDA approval in January based on its ability to reduce amyloid beta plaque, a marker of Alzheimer’s disease that’s believed to be associated with improved outcomes. But thanks to Medicare coverage restrictions, the launch won’t really gain steam until the drug secures a full FDA approval.”

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(Source: Fierce Pharma, June 9^th, 2023)