On April 11, 2023, the Federal Register included a notice that U.S. Food and Drug Administration (FDA) will convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on Friday, June 9, 2023 to discuss the LEQEMBI™ (lecanemab-irmb) data from Eisai’s Phase 3 Clarity AD clinical trial that serves as both the confirmatory, post-marketing requirement study for LEQEMBI’s accelerated approval and the basis of our supplemental Biologics License Application (sBLA) for the potential traditional approval of LEQEMBI. Eisai looks forward to hearing from diverse stakeholders, including patients, care partners, and medical experts, and to discussing the high-quality and highly statistically significant data from Eisai’s Phase 3 Clarity AD clinical trial.
The FDA approved LEQEMBI for the treatment of Alzheimer’s disease (AD) under the accelerated approval pathway on January 6, 2023, granted priority review of the sBLA, and established a PDUFA date of July 6, 2023. Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (patients with mild cognitive impairment or mild dementia stage of disease). LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the prestigious peer-reviewed medical journal, The New England Journal of Medicine. Based on the Clarity AD data, AD specialists, neurologists, patient advocacy organizations, professional societies, practicing physicians, and scientists, as well as people living with AD and their care partners, have shown strong support for access because of both the high quality of the data and the potential LEQEMBI has to provide clinically meaningful results.