KEY POINTS
- FDA extends review of weekly subcutaneous LEQEMBI IQLIK for early Alzheimer's initial treatment to Aug. 24, 2026
- Review delay follows a major amendment after an FDA request for additional information
- FDA has not raised concerns about approvability, while subcutaneous maintenance use was cleared in 2025
Eisai Co. and Biogen said the U.S. Food and Drug Administration has extended by three months its review of a supplemental biologics license application for weekly subcutaneous LEQEMBI IQLIK as an initial treatment for early Alzheimer's disease.
