The FDA has informed Eli Lilly that it plans to convene a panel of independent experts to learn more about the safety and efficacy of donanemab, the company's proposed Alzheimer's drug. The move delays an FDA decision on the drug until at least later this year.
"The FDA has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design," Eli Lilly said in a March 8 news release on the matter.
The drugmaker had anticipated FDA approval on donanemab during the first quarter of the year. Eli Lilly said federal regulators have not yet set a date for the advisory committee, though company officials expect it will take a few months to convene a meeting.
"The FDA did commit to us to move quickly, so we hope that they would then take action shortly after the advisory committee," Anne White, executive vice president of Eli Lilly and president of the company's neuroscience division, told The New York Times.
The Wall Street Journal reported that analysts still anticipate the FDA will approve the drug.
Officials with the Alzheimer's Drug Discovery Foundation said the FDA's move to seek independent expert opinion before making a decision on the drug is in line with the regulatory process for other amyloid plaque-targeting therapies.
"Today's FDA decision is not a setback, but another step forward in the drug approval process, with the regulatory agency doing its due diligence before the distribution of the drug to patients," Howard Fillit, MD, co-founder and chief science officer of the ADDF, said in a statement. "The decision to hold an advisory committee before granting approval follows the regulatory process that was used for the other drugs in this class, including Leqembi."
Leqembi, made by Eisai and Biogen, was approved last year.
Biogen and the FDA previously came under fire after the approval of another Alzheimer's drug, Aduhelm, which was controversial due to weak evidence of clinical benefit for patients. Early this year, Biogen said it was discontinuing the drug and would redirect efforts to Leqembi.