The FDA accepts BLA and grants priority review for lecanemab for ...
Eisai announced FDA accepted the Biologics License Application for lecanemab, an anti-amyloid beta antibody for early Alzheimer's treatment, under accelerated approval. A Phase 3 trial's results, expected Fall 2022, may confirm its clinical benefit. Eisai aims for traditional approval by Q1 2023, with BioArctic receiving a MEUR 15 milestone payment.
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The FDA accepts BLA and grants priority review for lecanemab for ...
Eisai announced FDA accepted the Biologics License Application for lecanemab, an anti-amyloid beta antibody for early Alzheimer's treatment, under accelerated approval. A Phase 3 trial's results, expected Fall 2022, may confirm its clinical benefit. Eisai aims for traditional approval by Q1 2023, with BioArctic receiving a MEUR 15 milestone payment.