The behavioral neurologist and medical director of the Toronto Memory Program provided perspective on how lecanemab’s FDA approval changes the capabilities of treating Alzheimer disease in its earliest stages. [WATCH TIME: 3 minutes]
WATCH TIME: 3 minutes
"If they’re successful and the FDA grants full approval, we don’t have this tenuous situation where approval could be withdrawn, and we have a much greater opportunity to have insurers fund the drug so that it can be much more available and accessible to patients."
On January 6, 2023, the FDA approved Eisai’s antiamyloid therapy lecanemab, marketed as Leqembi, for patients with early Alzheimer disease (AD), making it the second approved therapy in its class, behind Biogen’s aducanumab (Aduhelm), which received greenlight in June 2021. Both therapies were approved through the accelerated approval pathway, which states that confirmatory phase 4 studies must be conducted; however, Eisai also submitted a supplemental biologics license application (sBLA) supporting the conversion of the accelerated approval of the agent to a traditional approval.1
Study 201, a Bayesian design clinical trial that included 856 patients with early AD, served as the basis for the approval. At the end of the 18-month treatment period 10 mg/kg biweekly lecanemab reduced brain amyloid by a mean of 0.306 standardized uptake value ratio units from a baseline mean of 1.37. Additionally, this group had a 76% probability of achieving less decline on the primary end point, change on the Alzheimer Disease Composite Score, than placebo.2
To better understand the significance of this approval, as well as what it means for patients with AD, NeurologyLive® sat down with Sharon Cohen, MD, FRCPC. Cohen, a behavioral neurologist and medical director of the Toronto Memory Program at the University of Toronto, was an investigator on both Study 201 and Clarity AD (NCT03887455), the phase 3 confirmatory trial used in the most recent sBLA. In the interview, she discussed integrating the new therapy into society and the impacts a traditional approval could have vs accelerated approval.