The US regulator has been reviewing lecanemab as a treatment for patients with early-stage Alzheimer’s and amyloid plaques in the brain under a rolling biologics license application which completed in May.
The timeline puts lecanemab ahead of Lilly’s donanemab in the race to bring another amyloid drug for Alzheimer’s to market, although commercial prospects still look murky after the complete commercial failure of Biogen’s Aduhelm (aducanumab), approved by the FDA a year ago against the advice of the agency’s own advisors.
