Leqembi Self-Injected Alzheimer Drug Wins US Approval: Simplified Treatment Regimen for Patients.

Eisai and Biogen have received US approval for a new self-injected form of their Alzheimer's drug Leqembi, allowing patients to continue treatment at home with a weekly injection. The infused version costs $26,500/year, while the new self-injected form will be priced at $19,500/year. The drug, which lowers toxic brain protein levels, was initially approved in 2023 and has had a complicated treatment regimen.

Eisai Co., Ltd. and Biogen Inc. have received U.S. Food and Drug Administration (FDA) approval for a new self-injected form of their Alzheimer's drug, Leqembi. This approval allows patients to continue treatment at home with a weekly injection, marking a significant advancement in the treatment of early-stage Alzheimer's disease.

Leqembi, initially approved in 2023, has been administered intravenously at a cost of $26,500 per year. The new self-injected form, LEQEMBI® IQLIK™, will be priced at $19,500 per year, making it more accessible and convenient for patients. The FDA approval is based on clinical trials that showed the self-injected form maintains the drug's efficacy while reducing the need for healthcare visits and associated costs.

The new formulation, LEQEMBI IQLIK, is a subcutaneous autoinjector that can be administered in approximately 15 seconds. It is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD. After 18 months of LEQEMBI intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.

Clinical trials supporting the approval of the subcutaneous maintenance dosing showed that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months of IV treatment maintains clinical and biomarker benefits comparable to continued IV dosing. The safety profile of the subcutaneous formulation was similar to that of the IV treatment, with systemic reactions being much less common, at less than 1% compared to approximately 26% with IV infusions.

Eisai and Biogen plan to launch LEQEMBI IQLIK on October 6, 2025, in the U.S. The drug targets both amyloid plaque and protofibrils, which can impact tau downstream, offering a unique approach to managing AD. The new formulation provides patients with more flexibility in their treatment regimen, potentially improving adherence and quality of life.

References:
[1] https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-iqliktm-lecanemab-irmb-subcutaneous