FDA Extends Review of Eisai and Biogen’s LEQEMBI for Initial Treatment
Eisai and Biogen said the FDA has not raised concerns about the approvability of LEQEMBI IQLIK for initial treatment. The supplemental filing seeks approval to expand a once-weekly subcutaneous option for early Alzheimer’s disease, following FDA approval of a related maintenance dosing regimen. The Prescription Drug User Fee Act action date is Aug. 24, 2026.