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

June 28, 2021

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.

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