Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
The company's announced this week that the drug's Biologics License Application (BLA) has been accepted under the FDA's accelerated approval pathway, bringing a decision on the drug forward.
The application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023.
Follow-up to Aduhelm
The application to the FDA follows the partners’ troubled development of Aduhelm, another anti-amyloid antibody tackling build-up in amyloid plaque (understood to be a feature in Alzheimer's).
The drug hit a major stumbling block in April when the US Centers for Medicare & Medicaid Services (CMS) said it would limit coverage of the FDA-approved drug to clinical trials.
In its guidance for such drugs, the CMS placed emphasis on covering treatments granted traditional approval with proven clinical benefit (in contrast to the expedited accelerated approval which accepts surrogate biomarkers).
However, Eisai (which is the lead partner on lecanemab) said at the time that it remained committed to the accelerated approval pathway: stating that ‘Clarity AD has a robust design, which could meet the ‘high level of evidence’ criteria set forth by the CMS’.
A readout of primary endpoint data for this study is expected in the fall this year. In granting accelerated approval, the FDA has agreed that the results of this study, covering 1,795 patients, can 'serve as the confirmatory study to verify the clinical benefit of lecanemab'.
Traditional approval pathway to follow
Dependent upon the results of the Clarity AD clinical trial, Eisai intends to submit an application for traditional approval to the FDA by the end of March next year. In Europe, again based on the results of the Clarity AD study, Eisai plans to submit a new drug application by March.
In Japan, Eisai started submitting application data to the Pharmaceuticals and Medical Devices Agency (PMDA) in March under the prior assessment consultation system with the aim of obtaining early approval for lecanemab.
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.
With accelerated approval, a decision for lecanemab is likely to come before Eli Lilly’s donanemab: which also intends to use this pathway.