Biogen partner Eisai completes FDA submissions for injectable Alzheimer’s therapy
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Japanese drugmaker Eisai (OTCPK:ESAIY) (OTCPK:ESALF), Biogen's (NASDAQ:BIIB) partner for intravenous Alzheimer's therapy, Leqembi, has completed the rolling submission of a Biologics License Application (BLA) for an injectable version of the drug in the U.S.
With the BLA, the company seeks U.S. approval for the subcutaneous autoinjector for weekly maintenance dosing in patients with early Alzheimer's disease under the FDA's fast-track status.
Once the BLA is accepted, the FDA is expected to grant a target action date regarding its decision.
In July 2023, the regulator approved Leqembi for intravenous use with a biweekly dosing schedule in adults with Alzheimer's. At the time, the anti-amyloid agent was the first FDA-approved drug proven to slow the clinical progression of the memory-robbing disease.
A potential label expansion targeting monthly maintenance dosing of the drug is currently under the FDA review, with a target action date of January 25, 2025.
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