FDA Approves Leqembi IV Maintenance Dosing for Early Alzheimer's Treatment

BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's Supplemental Biologics License Application (sBLA) for Leqembi as a once every four weeks intravenous (IV) maintenance dosing. Leqembi is indicated for the treatment of Alzheimer's disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease in the U.S. (early Alzheimer's disease). This approval means that patients who have completed the biweekly initiation phase of 18 months have the option to transition to a once every four weeks 10 mg/kg dosing regimen.

Eisai has previously published data supporting the importance of continued ongoing treatment. Data from the off-treatment period between the Phase 2 core study and its long-term extension (LTE) showed that discontinuation of treatment is associated with reaccumulation of brain amyloid, and plasma and CSF biomarkers, and reversion to placebo rate of clinical decline.[1] In addition, recent data of three years of bi-weekly treatment across the Phase 3 Clarity AD core study and LTE, showed that Leqembi reduced cognitive decline on the CDR-SB by -0.95 relative to a matched natural history cohort – more than double the mean change from baseline relative to placebo on the CDR-SB at 18 months (-0.45) – showing expanded clinical and personally meaningful benefit for early AD patients.[2]

Alzheimer's disease is caused by a continuous underlying neurotoxic process that begins before and continues after plaque removal. Continuous administration of Leqembi is of great value to patients as Leqembi works to fight Alzheimer's Disease in two ways: not only rapidly clearing the amyloid-beta (Aβ) plaque, but it also works to fight the progressive nature of Alzheimer's disease by continuously clearing the highly toxic protofibrils that otherwise continue to cause neuronal injury.

The sBLA for the once every 4-week dosing regimen is based on modeling of observed data from the Phase 2 study and its long-term extension (LTE) as well as the Clarity AD study and its LTE study. Modeling simulations predict that transitioning to once every 4 weeks maintenance dosing after 18 months of biweekly treatment will maintain clinical and biomarker benefits of therapy.

Leqembi is already approved in the US, Japan, China, Great Britain and several other markets. In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval. Eisai has submitted applications for approval of lecanemab in 17 countries and regions. Furthermore, the FDA accepted Eisai's Supplemental Biologics License (BLA) for the Leqembi subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025.

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer's disease. BioArctic has the right to jointly commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

This information is information that BioArctic is obliged to make public pursuant to the Financial Instruments Trading Act. The information was released for public disclosure, through the agency of the contact persons below, on January 27, 2025, at 00:30 CET.

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