FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US

Rhea-AI Summary

BioArctic AB announced that the FDA has accepted their partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. The PDUFA action date is set for August 31, 2025.

Leqembi, indicated for early Alzheimer's disease treatment, could become the only FDA-approved anti-amyloid therapy offering convenient subcutaneous injection with at-home administration. The SC-AI 360 mg weekly maintenance regimen, following the biweekly intravenous initiation phase, is designed to maintain clinical and biomarker benefits with a 15-second injection process.

The treatment is already approved in the US, Japan, China, Great Britain, and received a positive CHMP opinion from EMA in November 2024. This new delivery method could reduce hospital visits and simplify the treatment pathway for Alzheimer's patients.

Positive

• Potential to be the only FDA-approved at-home injectable Alzheimer's treatment
• Quick 15-second injection process reduces administration time
• Could reduce healthcare facility visits and associated costs
• Already approved in major markets (US, Japan, China, Great Britain)
• Received positive CHMP opinion for European approval

Negative

• FDA approval pending until August 31, 2025
• Requires initial intravenous treatment phase before at-home administration

Insights

Medical Research Analyst

The FDA's acceptance of Eisai's BLA for Leqembi's subcutaneous autoinjector represents a pivotal advancement in Alzheimer's disease treatment delivery. The shift from intravenous to subcutaneous administration introduces significant advantages in both clinical practice and market positioning. The proposed 15-second weekly injection dramatically improves the treatment burden compared to current biweekly IV infusions.

The subcutaneous formulation could substantially reduce healthcare system costs by minimizing the need for infusion center visits and professional administration. This development aligns with healthcare's shift toward home-based care models and could expand Leqembi's accessibility to patients who face logistical barriers to regular infusion center visits.

The PDUFA date of August 31, 2025, sets a clear timeline for potential market implementation. If approved, Leqembi would gain a notable competitive advantage as the first and only subcutaneous anti-amyloid therapy for early Alzheimer's disease, potentially strengthening its market position against current and future competitors.

Market Research Analyst

This regulatory milestone could significantly impact BioArctic's market position and valuation. The subcutaneous formulation represents a strategic market expansion opportunity that could drive increased adoption rates and market penetration. With Leqembi already approved in major markets including the US, Japan, China and Great Britain, the subcutaneous delivery system could help capture a larger share of the growing Alzheimer's treatment market.

The home administration capability could be a game-changer for market adoption, potentially leading to higher patient compliance rates and sustained revenue streams. The simplified administration process addresses key barriers in the current treatment paradigm, which could translate to improved commercial performance and market share gains. For investors, this development signals potential revenue growth opportunities and strengthened competitive positioning in the Alzheimer's therapeutic space.

STOCKHOLM, Jan. 13, 2025 /PRNewswire/ --BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosingLeqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). Leqembi is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option. The Prescription Drug User Fee Act (PDUFA) action date has been set to August 31, 2025.

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

The SC-AI is expected to be simple and easy for patients and their care partners to use, and may reduce the need for hospital or infusion site visits and nursing care for IV administration, which will make it easier to continue maintenance administration and may contribute to further simplifying the treatment pathway for AD.

Leqembi is already approved in the US, Japan, China, Great Britain and 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.

The information was released for public disclosure, through the agency of the contact persons below, on January 14, 2025, at 01.00 CET.

For further information, please contact: 

Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80 

About lecanemab (Leqembi^®)

Lecanemab 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 (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab is approved in the U.S., Japan, China, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. Lecanemab's approvals in these countries, as well as the CHMP's positive opinion, were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, 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 microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

Eisai has also submitted applications for regulatory approval of lecanemab in several other countries and regions, including the European Union. In November 2024, the treatment received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval. A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was accepted by the U.S. Food and Drug Administration (FDA) in June 2024, with PDUFA date January 25, 2025. In January 2025, the rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was accepted in the U.S..

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Please find full US prescribing information here including Boxed WARNING.

About the collaboration between BioArctic and Eisai

Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to 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 of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com. 

 

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FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US

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SOURCE BioArctic

FAQ

When is the FDA decision date for Leqembi's subcutaneous autoinjector (BIOA)?

The FDA's PDUFA action date for Leqembi's subcutaneous autoinjector is set for August 31, 2025.

How long does the Leqembi subcutaneous injection process take?

The Leqembi subcutaneous injection process is expected to take approximately 15 seconds.

What markets has Leqembi already received approval in?

Leqembi has already been approved in the US, Japan, China, Great Britain, and other markets, with a positive CHMP opinion for European approval.

What is the dosing schedule for Leqembi's subcutaneous maintenance treatment?

The subcutaneous maintenance treatment consists of 360 mg weekly doses, following an initial biweekly intravenous initiation phase.

What advantages does the Leqembi subcutaneous autoinjector offer patients?

The autoinjector offers at-home administration, reduces need for hospital visits, simplifies treatment pathway, and provides more convenient maintenance dosing for Alzheimer's patients.