FDA green light for Leqembi subcutaneous formulation

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.

According to a statement from Biogen, Leqembi Iqlik will be launched on October 6, 2025. After 18 months of Leqembi (lecanemab-irmb) intravenous (IV) treatment at 10mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360mg subcutaneous injection using the Leqembi Iqlik autoinjector.