The Food and Drug Administration (FDA) late last week denied Ely Lilly’s request for expedited approval of the Alzheimer’s drug donanemab, citing the need for more clinical trials to test the safety and efficacy of the drug.
In a response letter to Lilly regarding its application for expedited approval, the FDA indicated that it had specifically requested the company provide data from at least 100 patients who had received a minimum of 12 months of continued treatment with the drug. The company said while their clinical trial of donanemab did include more than 100 patients, many patients were able to stop dosing after six months of treatment due to the speed of plaque reduction.
In its letter, the FDA cited the need for continued study of the drug by at least 100 patients for 12 months to effectively test the drug’s safety over time. No other deficiencies with the application were noted.
Donanemab is one of several experimental drugs in production that are designed to decrease the presence of amyloid plaque in patients with early Alzheimer’s disease and slow the progression of the disease. In early January, the FDA granted accelerated approval by drugmakers Eisai and Biogen for its drug lecanemab, which is used to treat to patients with early stage Alzheimer’s.
Lilly officials say the safety profile of donanemab from its TRAILBLAZER-ALZ trial was initially reported in the New England Journal of Medicine in 2021 and has remained consistent since its submission for accelerated approval to the FDA.
The company said it is continuing clinical trials and plans to submit an application for traditional approval of the drug by mid’ 2023.
“We anticipate this study will confirm the benefit and safety profile we observed in the TRAILBLAZER-ALZ Phase 2 study and believe that patients and physicians will be well served by having the full Phase 3 data available alongside our Phase 2 data when they need to make treatment decisions,” Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company, said in a company news release.
“We are committed to working with the FDA to ensure the fastest possible path to bring this potential medicine to patients in need,” she added.
