Eisai, Biogen launch subcutaneous Leqembi autoinjector in the U.S.

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced that a subcutaneous autoinjector form of lecanemab-irmb, sold as Leqembi Iqlik, is now available in the U.S. for the initiation of treatment in adults with early Alzheimer's disease, including those with mild cognitive impairment or mild dementia.

The autoinjector offers an alternative to intravenous infusion from the start of treatment. The approved initiation regimen consists of 500 mg administered once weekly as two consecutive 250 mg injections, each delivered in approximately 15 seconds. After 18 months of either intravenous or subcutaneous treatment, patients may transition to a maintenance dose of 360 mg once weekly via the autoinjector. Patients may also switch between intravenous and subcutaneous administration at any point during treatment.

The U.S. Food and Drug Administration approved the subcutaneous initiation regimen in July 2026. Regulatory applications for the subcutaneous initiation dose are under review in four other countries, including Japan and China.

Leqembi carries a boxed warning for amyloid-related imaging abnormalities (ARIA), which can include brain edema and microhemorrhage. Symptomatic ARIA occurred in 3% of patients in clinical trials, and serious ARIA symptoms were reported in 0.7%. Brain MRI monitoring is required before and during treatment.

Eisai and Biogen said support resources will be available to patients, including an instructions-for-use video, a welcome kit, and a companion app developed with Medisafe Ltd. The product will be distributed through the Leqembi Specialty Pharmacy Network, which includes CareMed Specialty Pharmacy and Walgreens Specialty Pharmacy. Eisai's Patient Assistance Program will provide the drug at no cost to eligible uninsured patients who meet financial need criteria.

Eisai serves as the lead for lecanemab's global development and regulatory submissions, with both companies co-commercializing the product.

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