FDA Accepts Leqembi sBLA for IV Maintenance in Early Alzheimer's Treatment

STOCKHOLM, June 10, 2024 – BioArctic AB’s partner, Eisai, has announced that the U.S. Food and Drug Administration (FDA) has accepted its Supplemental Biologics License Application (sBLA) for a less frequent monthly intravenous (IV) maintenance dose of lecanemab-irmb, known in the U.S. market as Leqembi. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of January 25, 2025. Leqembi is prescribed in the U.S. for the treatment of Alzheimer's disease (AD) in patients showing mild cognitive impairment or mild dementia, collectively termed as early-stage AD.

The proposed monthly IV maintenance regimen is intended for patients who have completed the biweekly IV initiation phase. The exact duration of this initiation phase is under discussion with the FDA. The monthly dosage aims to maintain effective drug levels to continue clearing toxic amyloid beta (Aβ) protofibrils, which are harmful to neurons. This sBLA relies on data from Phase 2 (Study 201) and Phase 3 (Clarity AD or Study 301) trials, including their open-label extensions.

Alzheimer's disease is characterized by the accumulation of toxic amyloid proteins. Continuous treatment is essential as this pathogenic process progresses throughout a patient’s life. Data from the referenced studies suggest that extending treatment with Leqembi beyond the initial 18-month period sustains benefits by continually removing toxic protofibrils. If approved, the monthly dosing regimen could make long-term treatment more manageable for patients and their caregivers while maintaining clinical and biomarker benefits.

In addition, Eisai has begun a rolling submission of a Biologics License Application (BLA) for a Leqembi subcutaneous autoinjector for weekly maintenance dosing, following its Fast Track designation by the FDA in May 2024.

Currently, Leqembi is approved in the U.S., Japan, China, and South Korea. Applications are under review in several other countries, including those in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

Eisai is responsible for the clinical development, regulatory applications, and commercialization of Lecanemab for Alzheimer's disease. BioArctic, which incurs no development costs for Lecanemab in AD, is entitled to regulatory approval payments, sales milestones, and royalties on global sales. BioArctic retains the right to commercialize Lecanemab in the Nordic region pending European approval, and both companies are currently preparing for joint commercialization in this region.

Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, targets both soluble and insoluble forms of amyloid-beta (Aβ). The approval of Leqembi was based on the Phase 3 Clarity AD study, which met all its primary and key secondary endpoints with significant results. These findings were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference and published in the New England Journal of Medicine.

Since July 2020, Eisai has been conducting the AHEAD 3-45 Phase 3 clinical study for individuals with preclinical AD. This public-private partnership with the Alzheimer’s Clinical Trial Consortium is funded by the National Institute on Aging, part of the National Institutes of Health. Additionally, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), led by Washington University School of Medicine in St. Louis, has been ongoing since January 2022 and includes Lecanemab as the primary anti-amyloid therapy.

BioArctic’s collaboration with Eisai dates back to 2005 and includes agreements for the development and commercialization of Alzheimer’s treatments. BioArctic is a Swedish biopharma company focusing on delaying or halting neurodegenerative diseases, utilizing its proprietary BrainTransporter™ technology to enhance treatment efficacy. Leqembi is the first drug proven to slow disease progression and reduce cognitive impairment in early Alzheimer’s. BioArctic’s B share is listed on Nasdaq Stockholm Large Cap.

Protofibrils, which are associated with AD-related brain injury and cognitive decline, are a primary target of Lecanemab, aimed at reducing neuronal damage and improving cognitive function.

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