FDA Accepts License Application for Subcutaneous Biologics Leqembi ® (lecanemab-irmb) for US Maintenance By Investing.com

STOCKHOLM, January 13, 2025 /PRNewswire/ —BioArctic AB (published) (Nasdaq Stockholm: BIOA B) today he announced that US Food and Drug Administration (FDA) accepted of BioArctic partner Eisai’s Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing Leqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia (common name until early AD ). Leqembi is the only FDA-approved anti-amyloid therapy that can potentially offer the convenience of subcutaneous injection with the option of home administration. The start date of the Prescription Drug User Fee Act (PDUFA) has been set at August 31, 2025.

The BLA is based on data from the Clarity AD Open Extension (Study 301) (OLE) and modeling of observed data. If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only AD treatment that can be administered subcutaneously at home using an autoinjector (AI). The injection process is expected to take an average of 15 seconds. The SC-AI 360 mg weekly maintenance regimen will allow patients who have completed the two-week intravenous (IV) initial phase, the exact period under discussion with the FDA, to receive weekly doses expected to maintain clinical and biomarker benefits.

SC-AI is expected to be simple and easy to use for patients and their care partners and may reduce the need for a hospital visit or infusion site visit and medical care for IV administration, which will facilitate continued maintenance administration and may contribute to further simplifying the pathway treatment of AD.

Leqembi is already approved in the US, Japan, China, Great Britain and other markets. IN November 2024the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency (EMA) recommends approval.

The data was released to the public, through the contact persons listed below, on January 14, 2025at 01.00 CET.

For additional information, please contact:

Oskar Bossonvice president of communications and IR
Email: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80

About lekanemab (Leqembi ^®)

Lekanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils) and insoluble forms of amyloid-beta (Aβ).

Lekanemab is approved in OUR, Japan, Chinaand several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. The approvals of Lecanemab in these countries, as well as the positive CHMP opinion, were primarily based on phase 3 data from Eisai’s global clinical trial Clarity AD, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhage, cerebral macrohemorrhage, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

Eisai has also filed for regulatory approval of lekanemab in several other countries and regions, including European Union. IN November 2024the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval. The application for a supplementary biologics license (sBLA) for less frequent intravenous maintenance dosing was accepted US Food and Drug Administration (FDA) in June 2024with a PDUFA date January 25, 2025. IN January 2025IN OUR.

Of July 2020Eisai’s ongoing Phase 3 clinical study (AHEAD 3-45) of lekanemab in people with preclinical AD, meaning they are clinically normal and have moderate or elevated levels of amyloid in the brain. The study is fully engaged in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Alzheimer’s Disease Clinical Trials Consortium which provides infrastructure for academic clinical trials of AD and related dementias in OURfunded by National Institute on Agingpart National Institutes of Health and Eisai. Of January 2022Tau NexGen Clinical Study for Dominant Inheritance AD (DIAD)conducted by the Dominantly Inherited Alzheimer’s Network Research Unit (DIAN-TU), which he leads Washington University School of Medicine in St. Louisis ongoing and includes lekanemab as a core anti-amyloid therapy.

You can find all US prescribing information here, including the boxed WARNING.

About cooperation between BioArctic and Eisai

Since 2005 BioArctic has a long-term cooperation with the company Eisai on the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most important agreements are the Lekanemab antibody development and commercialization agreement, which was signed in 2007, and the Leqembi reserve antibody development and commercialization agreement for Alzheimer’s disease, which was signed in 2015. In 2014, Eisai and Biogen (NASDAQ) 🙂 entered into a joint contract on the development and commercialization of lekenemab. Eisai is responsible for the clinical development, application for market approval and commercialization of products for Alzheimer’s disease. BioArctic has the right to commercialize lekanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordic region together with Eisai. BioArctic has no development costs for lekanemab for Alzheimer’s disease and is entitled to payments related to regulatory approvals and sales milestones, as well as royalties on global sales.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharmaceutical company focused on innovative treatments that can delay or halt the progression of neurodegenerative diseases. The company invented Leqembi ® (lecanemab) “the first drug in the world that is proven to slow the progression of the disease and reduce cognitive impairment in the early stages of Alzheimer’s disease. Leqembi was developed together with of BioArctic partner Eisai, which is responsible for regulatory interactions and commercialization on a global scale. Apart from Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson’s disease and ALS as well as additional projects against Alzheimer’s disease. Several projects use the company’s proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to increase treatment efficacy. of BioArctic B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, visit www.bioarctic.com.

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