Eli Lilly will face questions from a panel of Alzheimer’s experts on June 10, setting up an approval decision for donanemab after a surprise delay by the FDA in early March.
The drug will go before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, the company said in a statement Tuesday. Lilly has previously said that the FDA is especially interested in donanemab’s safety, the company’s proposal to stop treatment once the drug clears up amyloid plaques, and analyses that suggest levels of the brain protein tau can predict how well a person responds to treatment.
Lilly has submitted a data package that includes a positive, placebo-controlled Phase 3 study that enrolled 1,736 participants across eight countries.
In the study, Lilly found that donanemab worked better in patients under 75 years of age with low-to-medium tau levels, slowing cognitive decline by nearly 50%. But patients with high tau levels — a sign of more advanced disease — saw little benefit.
If approved, which FDA Commissioner Rob Califf has hinted is likely, donanemab will compete with Eisai and Biogen’s amyloid-targeted monoclonal antibody, Leqembi. Sales of Leqembi have gotten off to a slow start after the drug was approved by the agency last year.