▎WuXiEdited by Kant Content Team

Eisai and Biogen recently announced that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. FDA for the Leqembi (lecanemab) subcutaneous auto-injector intended for weekly maintenance dosing. The product had previously been granted Fast Track designation by the FDA.If approved, the Leqembi auto-injector will be availableAlzheimer's Disease (AD)）The entire injection process takes an average of only about 15 seconds when used by patients in medical institutions or at home.

This BLA submission is primarily based on the data from the Clarity AD (Study 301) open-label extension (OLE) trial and modeling of the observed data.Currently under review is the weekly 360 mg Leqembi subcutaneous auto-injector maintenance regimen. Patients who have completed the initial treatment phase of biweekly intravenous (IV) infusions will receive a weekly maintenance dose to sustain effective drug concentration for the continuous clearance of highly toxic fibrils.These fibrils even inADEven after the clearance of β-amyloid (Aβ) plaques in the patient's brain, neuronal damage may still be triggered.

Leqembi has been approved in the United States, Japan, China, South Korea, Israel, the United Arab Emirates, and the United Kingdom. Eisai has also submitted approval applications for Leqembi in 10 countries and regions, including the European Union (EU). In June 2024, the U.S. FDA accepted Eisai's supplemental Biologics License Application (sBLA) for Leqembi’s monthly intravenous maintenance dosing, with a PDUFA target date of January 25, 2025.

Leqembi can specifically bind to soluble oligomers of β-amyloid.In the brains of AD patients, elevated levels of β-amyloid lead to their aggregation from monomers into dimers and soluble oligomers, which eventually further accumulate into amyloid plaques in the brain. Scientific research indicates that soluble oligomers of β-amyloid exhibit stronger cytotoxicity than monomers. Leqembi neutralizes and clears these toxic soluble oligomers by binding to them.

In January last year, the FDA based onLeqembiThe effect of reducing amyloid plaque deposition in the patient's brain,Accelerated ApprovalIts marketing application for the treatment of Alzheimer's disease. New drugs approved for marketing through the accelerated approval pathway are required to conduct confirmatory clinical trials to verify their clinical efficacy. In June 2023,At the advisory meeting held by the U.S. FDA,Attending ExpertsWith a unanimous vote of 6 to 0, believing that the results of the Phase 3 clinical trial CLARITY AD provide supportLeqembiFull approval.SubsequentlyLeqembi received FDA approval in the United States in July of the same year.Full Approval。Industry media Endpoints pointed out,This is the first full FDA approval for an Alzheimer's disease drug in 20 years.