On 5 July, the Toyko-based pharmaceutical company, Eisai, together with partners at Biogen, announced that the US Food and Drug Administration had accepted their biologics licence application (BLA) for lecanemab, under the accelerated approval pathway. Lecanemab, also known as BAN2401, is an antibody that targets amyloid protofibrils, which build up in harmful amyloid plaques within the brain during the development of Alzheimer’s disease (AD). Clarity AD, a phase 3, randomised, placebo-controlled trial of lecanemab, is currently evaluating the efficacy of the drug in participants with mild cognitive impairment or mild dementia due to AD. Ongoing analyses indicate that lecanemab is efficient at clearing amyloid plaques from the brain when delivered fortnightly at a 10mg/kg dose via intravenous infusion.
Clarity AD completed enrolment in March 2021, recruiting 1,795 participants, with primary endpoint results expected in late 2022. The FDA has agreed that the Clarity AD trial, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Acceptance of the lecanemab BLA by the FDA under the accelerated approval pathway means that a decision is expected early in 2023. In their press release, Eisai stated that, depending on the results of the Clarity AD study, they will submit a traditional application for FDA approval by March 2023. They expect to file concomitant applications for approval with the EMA and the Japanese Regulator, PMDA.
