Eisai and Biogen Receive FDA Approval for Leqembi Iqlik Subcutaneous Injection for Alzheimer's Treatment

Eisai and Biogen announced FDA approval for Leqembi Iqlik, a subcutaneous autoinjector for Alzheimer's disease maintenance dosing. The new weekly 360 mg injection can be administered in 15 seconds and is indicated for patients with mild cognitive impairment or mild dementia stage of disease in the U.S. This approval allows patients to switch from IV infusions to the new weekly subcutaneous injection.

Eisai and Biogen have announced that the U.S. Food and Drug Administration (FDA) has approved Leqembi Iqlik, a subcutaneous autoinjector for the maintenance treatment of early Alzheimer's disease. The new weekly 360 mg injection can be administered in approximately 15 seconds, offering an at-home alternative after 18 months of initial intravenous (IV) treatment [1].

The approval of Leqembi Iqlik represents a significant advancement in Alzheimer's disease management. The device delivers the same medication (lecanemab-irmb) but in a format that can be administered at home, significantly reducing the burden of regular infusion center visits. Clinical trials demonstrated that transitioning to the weekly autoinjector maintained comparable benefits to IV dosing, with an improved safety profile showing less than 1% systemic reactions compared to 26% with IV infusions [1].

The device will launch on October 6, 2025, in the U.S., supported by patient assistance programs and dedicated navigators to help with treatment access. Long-term data showed that at 48 months, Leqembi reduced cognitive decline by 1.75-2.17 points on the CDR-SB scale compared to expected natural disease progression [1].

The approval of Leqembi Iqlik will increase treatment accessibility and adherence for Alzheimer's patients after 18 months of IV therapy. This subcutaneous autoinjector is the first and only anti-amyloid treatment to offer an at-home injection for continued treatment of this progressive, relentless disease [1].

References:
[1] https://www.stocktitan.net/news/BIIB/fda-approves-leqembi-iqliktm-lecanemab-irmb-subcutaneous-injection-r9k723nqvbc4.html