FDA delays action on promising Alzheimer's drug donanemab, drugmaker Eli Lilly says
The U.S. Food and Drug Administration has delayed action for the promising Alzheimer’s treatment donanemab, the drug manufacturer said on Friday.
Eli Lilly said the FDA would wait on ruling about donanemab, a drug for older people with early symptoms of Alzheimer’s disease, until after the first quarter of 2024 while the federal agency convenes an advisory committee to evaluate it. The pharmaceutical company said in a news release that the FDA has not yet set a meeting date for the central nervous system drug advisory committee. The company said it is “unusual” for the committee to meet after the agency’s anticipated action date, however, the advisory meeting for donanemab follows similar processes for two similar therapies the FDA has approved.
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"We are confident in donanemab's potential to offer very meaningful benefits to people with early symptomatic Alzheimer's disease,” Anne White, executive vice president of Eli Lilly and Company, said in a statement. She called it “unexpected" that an advisory committee would be convened "at this stage in the review process,” adding that Lilly officials look forward to sharing the results of the company's study.
The FDA declined to comment, its standard protocol with pending drug applications and approvals.
Eli Lilly's study, published in July in the Journal of the American Medical Association, looked at the effects of donanemab on more than 1,700 people – aged 60 to 85 and across eight countries – with early Alzheimer’s disease. The study found the drug slowed cognitive and functional decline by about 35% compared with participants in a placebo group. The differences were measured daily based on patients' functioning during activities such as driving, managing finances and discussing current events.
Alzheimer's disease experts remain optimistic about donanemab, which slowed memory and thinking problems in people with early stages of the disease in late-stage clinical trials, Eli Lilly reported.
Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said in a statement that the FDA's decision "is not a setback." He said the FDA is "doing its due diligence" before the drug is approved for distribution to patients.
Donanemab is part of a class of drugs for patients with early stages of Alzheimer's disease. The drugs target amyloid, a sticky protein that forms plaques thought to scuttle memory and thinking, on the brains of Alzheimer's patients. For more than 20 years, pharmaceutical companies have developed drugs that sought to clear these plaques from patients' brains. In January 2023, Eisai and Biogen received FDA approval to sell Leqembi for patients in the early stages of the disease. In 2021, Biogen's Aduhelm was the first to gain approval based on studies that delivered mixed results − an approval that prompted investigations from two U.S. House Committees. Biogen eventually discontinued Aduhelm.
The company said it is continuing to study donanemab in multiple clinical trials.