
FDA rejects accelerated approval for Eli Lilly’s Alzheimer’s drug, donanemab
pharmafile | January 20, 2023 | News story | Research and Development |
Eli Lilly has announced that its accelerated approval bid for Alzheimer’s disease drug, donanemab, has been rejected by the FDA. The request was rejected on the grounds that a limited number of patients had at least 12 months of exposure to the drug throughout the company’s clinical trial.
Lilly was hoping that donanemab would be approved in order to treat early cases of symptomatic Alzheimer’s disease.
The application follows Lilly’s phase 2 trial which demonstrated a decrease in amyloid plaque in the patients’ brains, which is often used as a surrogate biomarker for the efficacy of drugs against Alzheimer’s disease. Drugs can gain FDA accelerated approval based on biomarker evidence, as long as the company conducts a confirmatory trial in the future to demonstrate the drug’s efficacy.
Lilly is currently undertaking a phase 3 trial, known as TRAILBLAZER-ALZ 2, with Lilly hoping that this will confirm the drug’s efficacy and lead to its approval. Following the rejection of donanemab’s accelerated approval application, Lilly will have to wait for the results of this trial and undertake a full application before gaining approval.
This rejection puts Lilly behind Eisai and Biogen who gained accelerated approval for Leqembi (lecanemab).
Lilly explained the rejection in a press release, stating: “While the trial included more than 100 patients treated with donanemab, due to the speed of plaque reduction, many patients were able to stop dosing as early as six months of treatment, resulting in fewer than 100 patients receiving 12 months of donanemab.”
Betsy Goodfellow






