Biogen, Eisai win full FDA approval for Alzheimer's drug Leqembi
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The US FDA on Thursday fully approved the Alzheimer's drug Leqembi, developed by Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY), converting its accelerated approval into a regular approval for adults with mild form of the disease.
Last month, a group of independent advisors to the FDA voted unanimously to recommend full approval for the companiesâ supplementary Biologics License Application (sBLA) for Leqembi (lecanemab). The agency cleared the anti-amyloid agent under its accelerated approval early this year.
The sBLA is backed by data from Eisai's (OTCPK:ESALF) global phase 3 trial called Clarity AD, which met its primary endpoint, indicating that the Leqembi injection slowed cognitive and functional decline in Alzheimerâs patients by as much as 27% compared to placebo over 18 months.
The decision is crucial for Biogen (BIIB) and Eisai (OTCPK:ESALF) to obtain Medicare coverage for Leqembi. In June, the Centers for Medicare and Medicaid Services (CMS), which administers the federal health insurance program, indicated that the agency would cover Alzheimerâs therapies subject to full approval from the FDA.
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