BioArctic AB‘s partner Eisai has announced that the company has submitted a supplemental Biologics License Application (sBLA) for its drug Leqembi to the US Food and Drug Administration (FDA).
According to a report by Pharmabiz, the application has been submitted for the intravenous (IV) maintenance dosing of the drug. Leqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
Reportedly, Eisai had aimed to submit a Biologics License Application (BLA) for weekly maintenance therapy using subcutaneous (SC) administration in March 2024.
To respond to the FDA’s recent requirement of additional three-month immunogenicity data at the proposed maintenance dose of 360 mg weekly, Eisai planned to initiate a rolling BLA for lecanemab SC maintenance in the first quarter 2024, under lecanemab’s existing Fast Track and Breakthrough Therapy designations, the company stated.
However, Eisai was recently informed by the FDA that a Fast Track designation specific for the SC formulation is needed to receive rolling review. Following the guidance, Eisai submitted a request for Fast Track designation for the SC formulation and will initiate a rolling submission should the FDA grant this designation. The Fast Track designation will be determined within 60 days from the March 2024 submission.
AD is an ongoing neurotoxic process that begins before and continues after plaque deposition. There is an urgency to treat early AD because early and ongoing treatment can slow the progression of AD and continuing treatment may prolong the benefit even after plaque is cleared from the brain. The earlier mild cognitive impairment (MCI) due to AD and mild AD dementia are diagnosed and treated, the greater the opportunity for the patient to benefit. Continued maintenance dosing is intended to maintain the clinical and biomarker benefits with a dosing regimen that may be more convenient for some patients and their care partners.
Leqembi is now approved in the US, Japan and China, and applications have been submitted for review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan, Singapore, and Switzerland.
The drug 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.
According to reports, Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently, Eisai and BioArctic are preparing for joint commercialization in the region.
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, Pharmabiz reported.
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, it stated.
