LEQEMBI Gains Additional Indication in Maintenance Dosing for Early Alzheimer’s Disease with FDA Approval

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Japan-based Eisai and US-based Biogen announced on Jan. 27, 2025 that FDA has approved a supplemental biologics license application (sBLA) for a once-every-four-weeks dosing of lecanemab-irmb (US brand name LEQEMBI) as intravenous (IV) maintenance treatment for early Alzheimer’s disease (AD).

Lecanemab-irmb in the United States is indicated for treating AD in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (i.e., early AD). After an initiation phase of 18 months where patients are treated with the therapy once every two weeks, they can either transition to maintenance dosing, which comprises a regimen of 10 mg/kg once every four weeks or may continue with the regimen of 10 mg/kg once every two weeks.

The sBLA was submitted based on modeling of observed data from a Phase II study (Study 201) and a long-term extension (LTE) as well as another study, the Clarity AD study (Study 301), and its respective LTE study. The modeling simulations predicted that transitioning to a once-every-four-weeks maintenance dosing after 18 months of the initiation phase will maintain clinical and biomarker benefits of the therapy, according to a company press release (1).

A progressive disease, AD is caused by a continuous underlying neurotoxic process. This process begins before and continues after plaque removal (2–4). Lecanemab-irmb works on AD in two ways. The first is by continuously clearing protofibrils, and the second is by rapidly clearing plaque. The importance of these two actions is that lecanemab-irmb can clear highly toxic protofibrils with continuous administration. It is these protofibrils that can continue to cause neuronal injury even after amyloid-beta (Aβ) plaques have been cleared from the brain, according to Eisai in the press release (1).

Besides the US, lecanemab-irmb is approved in Japan, China (including Macau), South Korea, Hong Kong, Israel, United Arab Emirates, Great Britain, and Mexico. The therapy also received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2024, recommending approval in Europe. Meanwhile, in January 2025, FDA also accepted a sBLA for a subcutaneous autoinjector that would administer lecanemab-irmb as a weekly maintenance dose. FDA has set the Prescription Drug User Fee Act action date for Aug. 31, 2025 (1).

“Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product, and Eisai having final decision-making authority,” Eisai stated in the press release (1). Eisai and Biogen have been collaborating on the joint development and commercialization of AD therapies since 2014.

Lecanemab resulted from a strategic research alliance between Eisai and Sweden-based BioArctic, a research-based biopharma company, to develop and commercialize AD treatments, which began in 2005. Eisai gained the global rights to study, develop, manufacture, and market lecanemab for treating AD according to an agreement with BioArctic in December 2007.

References

1. Eisai. FDA Approves LEQEMBI (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease. Press Release. Jan. 27, 2025.
2. Eisai. LEQEMBI (lecanemab-irmb) Injection, for Intravenous Use. Package insert.
3. Iwatsubo, T.; Irizarry, M.; van Dyck, C.; et al. Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study Evaluating Lecanemab in Early Alzheimer’s Disease. Presentation at CTAD Conference, San Francisco, Calif., Nov. 29–Dec. 2, 2022.
4. Hampel, H.; Hardy, J.; Blennow, K.; et al. The Amyloid-β Pathway in Alzheimer’s Disease. Mol. Psychiatry 2021, 26 (10), 5481–5503. DOI: 10.1038/s41380-021-01249-0