Eli Lilly to File BLA Later in 2021 Using Aducanumab Approval Strategy

Eli Lilly plans to pursue accelerated approval of its Alzheimer’s disease treatment donanemab, using the same fast-track pathway Biogen used for its controversial Alzheimer’s drug Aduhelm.

Lilly had previously planned to seek approval of donanemab following results from an ongoing phase 3 study with a target enrollment of 1,500 patients, expected to conclude by the end of 2023. But the company said it now plans to file a Biologics License Application (BLA) with the FDA later this year.

Lilly’s antibody has already secured Breakthrough Therapy designation based on positive phase 2 trial results showing the drug slowed disease progression vs. placebo. The small study enrolled just 272 patients.