FDA green light for Leqembi subcutaneous formulation

30 August 2025

The US Food and Drug Administration (FDA) on Friday approved a subcutaneous (SC) formulation of Biogen (Nasdaq: BIIB) and Eisai’s (TYO: 4523) Alzheimer’s disease treatment Leqembi (lecanemab), branded as Leqembi Iqlik, for weekly maintenance dosing following the 18-month IV initiation phase.

This is a major advancement that opens the door for faster and simpler drug delivery and paves the way for combination therapies – the same strategy that revolutionized cancer care, the FDA said.

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