The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA), under the accelerated approval pathway, for lecanemab for the treatment of mild cognitive impairment due to Alzheimer disease (AD) and early AD with confirmed presence of amyloid pathology in the brain.
Lecanemab is a humanized monoclonal antibody that works by selectively binding to, neutralizing and eliminating soluble toxic amyloid beta aggregates. The application is supported by data from a phase 2b study (ClinicalTrials.gov Identifier: NCT01767311), which included 856 individuals with early AD and confirmed amyloid pathology.
Findings showed that treatment with lecanemab was associated with reduced brain amyloid beta plaque, correlating with improvements in cognitive decline based on the Alzheimer Disease Composite Score, the Clinical Dementia Rating-Sum-of-Boxes, and the Alzheimer Disease Assessment Scale-Cognitive Subscale.
The Company is currently investigating lecanemab in early AD in a confirmatory phase 3 study (Clarity AD; ClinicalTrials.gov Identifier: NCT03887455). The readout of the primary endpoint data is expected in the fall of 2022.
A Prescription Drug User Fee Act (PDUFA) target date of January 6, 2023 has been set for the application.
“The acceptance of lecanemab’s BLA with priority review is an important milestone in serving people living with Alzheimer’s disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer’s disease,” said Haruo Naito, Chief Executive Officer at Eisai.
A separate phase 3 study (AHEAD 3-45; ClinicalTrials.gov Identifier: NCT04468659) is evaluating lecanemab in participants with preclinical AD and elevated amyloid, and in those with early preclinical AD and intermediate amyloid.
The US FDA accepts and grants Priority Review for Eisai’s Biologics License Application of lecanemab for early Alzheimer’s disease under the accelerated approval pathway. News release. Eisai Co., Ltd. Accessed July 6, 2022. https://www.prnewswire.com/news-releases/the-us-fda-accepts-and-grants-priority-review-for-eisais-biologics-license-application-of-lecanemab-for-early-alzheimers-disease-under-the-accelerated-approval-pathway-301580919.html