Lilly's Alzheimer’s Drug Donanemab Faces Last-Minute FDA Delay Amid Advisory Panel Review

Intelligent Finance News learned that,Eli LillyEli Lilly and Company's (LLY.US) Alzheimer's drug donanemab faces further delays in gaining approval, as the U.S. Food and Drug Administration (FDA) plans to hold an external advisory committee hearing to discuss the safety and efficacy of this therapy; this is a significant surprise, as the FDA was originally expected to rule on the approval of the drug within a few weeks. In a statement on Friday, Eli Lilly and Company said that the agency wanted to hear from external experts "to further understand topics related to the evaluation of donanemab’s safety and effectiveness." The meeting date has not yet been determined.

In a large trial, the drug can remove a toxic protein called amyloid from the brains of Alzheimer's patients and help slow cognitive decline. In the study, side effects included brain swelling and brain bleeding, which require regular monitoring to detect these issues early before problems arise.

In an interview, executives of Eli Lilly and Company stated,FDA's last-minute call for an external committee may delay the decision on the drug by several months, as the agency needs time to organize and schedule the meeting.Anne White, Executive Vice President and President of Eli Lilly Neuroscience, said, "We only recently learned" that the agency had decided to hold a hearing.

She said that, among other things, the FDA wanted to explore the "unique aspects" of Eli Lilly and Company's main donanemab trial, including the fact that some patients were able to stop taking the drug after all amyloid was cleared from their brains, as well as unspecified topics related to safety. She also mentioned that the FDA has expressed a desire to quickly organize a hearing.

Although advisory panel hearings are common before major drug approvals, Eli Lilly and Company described the decision to hold a hearing at such a late stage as "unexpected" and "unusual." Nevertheless, the company's executives are confident that the drug offers significant benefits to patients.

Eli Lilly and Company initially applied for accelerated approval based on Phase II trial results showing that the drug could reduce amyloid-beta levels in the brain. However, in January 2023, the FDA rejected granting this conditional approval and requested that Eli Lilly submit a traditional drug application, which includes data from larger-scale Phase III trials — a submission the company made last year. In November, Eli Lilly executives stated that the FDA subsequently requested additional time to review these supplementary data, postponing the final decision until early this year.

Before this delay, Eli Lilly repeatedly stated that a final decision would be made by the end of the first quarter.Just two days ago, executives at Eli Lilly were still insisting that everything about the review was proceeding normally. "It's been a completely normal experience so far. Everything is normal to my knowledge," said Andrew Adams, senior vice president of the pharmaceutical company, during a presentation Wednesday at the TD Cowen investor conference. "You have to ask the agency’s view, but from our perspective, everything is normal."

If the drug is approved, it will compete with Japanese company Eisai's drug Leqembi, which received full FDA approval in July for the treatment of Alzheimer's disease.

Editorial Responsibility: Guo Mingyu