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January 27, 2026

FDA to review Eisai’s Leqembi Iqlik sBLA for Alzheimer’s

Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics licence application (sBLA) submitted by the former for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector (SC-AI) as a starting dose for early Alzheimer’s disease.

Alzheimer’s disease is characterised by amyloid beta and tau pathologies, driven by ongoing neurotoxicity from protofibrils. Credit: StanislavSukhin / Shutterstock.com.