Eli Lilly Chases FDA Nod for Investigational Alzheimer’s Therapy

Eli Lilly has announced that it is pursuing accelerated approval for the investigational Alzheimer’s drug donanemab — and that it also plans to evaluate the therapy compared to Biogen’s Aduhelm (aducanumab) in a head-to-head study.

Lilly said it had initiated a rolling submission of its donanemab Biologics License Application with the FDA, notably quite far ahead of phase 3 study read-outs that won’t be available until February 2023.

In other words, in a move signifying how the Alzheimer’s landscape has shifted since Aduhelm’s controversial accelerated approval, Lilly is hoping to nab an early clearance before late-stage trial data provide confirmation of donanemab’s benefit. The drug previously secured FDA Breakthrough Therapy designation in June, based on promising phase 2 results.