FDA panel recommends full approval for Biogen, Eisai Alzheimer's drug
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An advisory panel of the US Food and Drug Administration has voted unanimously to recommend full approval of Biogen (NASDAQ:BIIB) and Eisai's (OTCPK:ESALF) (OTCPK:ESAIY) Alzheimer's disease drug Leqembi, which would boost the drug's chances of being covered by Medicare.
The panel voted 6 to 0 for the drug. While the FDA is not bound to the recommendations of its expert panels, it generally follow them. 
Trading of Biogen shares was halted Friday ahead of the vote.
Leqembi, also known as lecanemab, received accelerated approval from the FDA late last year. Because it has yet to receive full regulatory approval, Medicare has only covered the drug for participants in its clinical trials. 
Earlier this month, Chiquita Brooks-LaSure, who heads the Centers for Medicare and Medicaid Services, said that Alzheimer's drugs would be covered by Medicare if they receive full, traditional approval. 
The FDA is slated to make a decision on whether to grant full approval for Leqembi by July 6. Eisai is the lead developer of the drug, with Biogen assisting its its commercialization.
More on Leqembi:
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