FDA Action Update, May 2026: Approvals, Priority Review, and Extension of Review
• The FDA extended its review of a supplemental biologics license application (sBLA) submitted by Eisai and Biogen on May 8, 2026. • The application concerns a once-weekly subcutaneous autoinjector starting regimen for lecanemab-irmb (Leqembi Iqlik), used to treat early Alzheimer disease. • This regulatory delay pushes the Prescription Drug User Fee Act (PDUFA) action date to August 24, 2026.
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