Biogen (NASDAQ:BIIB) tumbled in early trading Friday, after being halted Thursday on news that the Food and Drug Administration approved Biogen and Esai’s Alzheimer’s treatment drug Lequembi. Medicare also announced it will cover payments for the treatment.
The FDA on Thursday fully approved Leqembi, developed by Biogen and Eisai converting its accelerated approval into a regular approval for patients with mild-to-moderate forms of the disease.
Last month, a group of independent advisors to the FDA voted unanimously to recommend full approval for the companies’ 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 global phase 3 trial called Clarity AD, which met its primary endpoint, indicating that the Leqembi injection slowed cognitive and functional decline in Alzheimer’s patients by as much as 27% compared to placebo over 18 months.
The decision was crucial for Biogen and Eisai 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 Alzheimer’s therapies subject to full approval from the FDA.
It cautions that Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.
Shares fell $2.99, or 1.1%, $282.00
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