Eisai and Biogen Report the US FDA’s Acceptance of sBLA and Granted Priority Review for Leqembi (lecanemab-irmb) to Treat Alzheimer’s Disease
Shots:
- The US FDA has accepted sBLA for Leqembi (100mg/mL inj. for IV use) supporting the conversion of the accelerated to a traditional approval. The application also granted priority review with an expected PDUFA date of July 6, 2023
- The sBLA was based on the P-III trial (Clarity AD) evaluating lecanemab (10mg/kg, IV, BIW) in a ratio (1:1) in 1795 patients at 235 sites in North America, the EU, & Asia. The trial met its 1EPs & 2EPs with highly statistically significant results which were presented at Clinical Trials on Alzheimer's Disease conference and published in the NEJM
- Leqembi is a humanized IgG1 mAb directed against aggregated soluble & insoluble forms of Aβ that were approved under the Accelerated Approval Pathway for AD
Ref: GlobeNewswire | Image: EISAI
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