Lilly said the Food and Drug Administration wants information from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. The drugmaker gave the update after markets closed on Thursday.
The potential treatment aims to clear a plaque from the brain that is a key hallmark of the mind-robbing disease.
Lilly said it had more than 100 patients in the study used for its accelerated approval application. But many were able to stop taking the drug as early as 6 months into treatment due to the reduction in plaque.
The FDA’s accelerated approval program allows drugs to launch in the US based on promising early results, before they’re a confirmed benefit to patients. The agency granted accelerated approval earlier this month to another Alzheimer’s drugs, Leqembi from Japan’s Eisai.
Lilly is still seeking full approval for its drug. The company expects to report early results from a late-stage study in the second quarter.
The drugmaker may have to add data from that research to its application for accelerated approval. A Lilly spokeswoman said the company is working with the FDA on determining next steps to take.
SVB Securities analyst David Risinger called the accelerated approval delay “immaterial.” He said in a research note that the drug’s sales prospects depend more on the late-stage study the drugmaker is wrapping up.
Shares of Indianapolis-based Eli Lilly and Co. slipped more than $4, or about 1 percent, to $346 Friday morning. Broader indexes climbed slightly.