FDA Extends Review of Eisai, Biogen Alzheimer's Drug

Fonte: International Business Times

KEY POINTSFDA extends review of weekly subcutaneous LEQEMBI IQLIK for early Alzheimer's initial treatment to Aug. 24, 2026Review delay follows a major amendment after an FDA request for additional informationFDA has not raised concerns about approvability, while subcutaneous maintenance use was cleared in 2025 The agency pushed its decision on weekly subcutaneous LEQEMBI IQLIK for early Alzheimer’s initial treatment to Aug. 24 after seeking additional information.