Biogen, Eisai Win FDA Nod for At-Home Alzheimer's Drug Leqembi Iqlik
The new subcutaneous autoinjector offers a more convenient weekly maintenance option for patients after initial IV treatment.
Federal health regulators have approved Leqembi Iqlik, a weekly at-home autoinjector for patients with early-stage Alzheimer's disease, a major step forward in treatment accessibility for the memory-robbing condition. The Food and Drug Administration's decision, announced by partners Eisai and Biogen Inc., provides a much-anticipated alternative to the intravenous infusions currently required.
The new subcutaneous version is designed for maintenance dosing after a patient has completed an 18-month initiation phase with the intravenous form of Leqembi. The single-dose autoinjector, which can be administered in about 15 seconds, is expected to significantly ease the treatment burden for patients and their caregivers, particularly those in rural areas with limited access to infusion centers.
"This approval could be a game changer in Alzheimer's treatment," said Katsuya Haruna, a senior executive at Eisai, in an interview. The at-home option not only enhances patient convenience but also frees up capacity at infusion clinics for new patients starting treatment.
Clinical data submitted to the FDA showed that the weekly subcutaneous injection maintained clinical and biomarker benefits comparable to the IV version, effectively slowing cognitive decline in patients. Critically, the safety profile was improved, with systemic injection-related reactions dropping to less than 1% compared to 26% for IV infusions. The risk of amyloid-related imaging abnormalities (ARIA), a known side effect of this class of drugs, was similar to that of the infused version.
Eisai, which leads the commercialization, plans to launch Leqembi Iqlik in the U.S. on October 6, 2025. The approval is a key part of the company's strategy to reach blockbuster sales status for the Leqembi franchise, targeting revenues between $1.7 billion and $1.9 billion by its 2027 fiscal year. The company also confirmed it would seek approval for a subcutaneous version for the initial treatment phase.
The convenience of an at-home option is seen as a crucial factor in encouraging long-term adherence to the therapy, which is designed to be a continuous treatment to keep the disease's progression at bay.