Lilly's Alzheimer’s Drug Donanemab Faces FDA Setback Due to Insufficient Long-Term Data

SmartCom APP learned that Eli Lilly (LLY.US) said on Thursday that the U.S. Food and Drug Administration (FDA) refused to accelerate the approval of the company's experimental Alzheimer's drug donanemab because the company did not submit enough trial data from patients who had received at least one year of treatment.

Eli Lilly's donanemab is a drug designed to clear amyloid plaques from the brains of patients with early Alzheimer's disease. Eli Lilly stated that the FDA has sent it a complete response letter regarding donanemab, which typically outlines the issues and conditions that must be addressed for approval.

Eli Lilly stated that the FDA sent this letter "because of the limited number of patients with at least 12 months of drug exposure data provided in the submission." The company mentioned that in the interim trial, once the patients' amyloid plaques were cleared, they would stop the treatment. The company added that 40% of patients would discontinue treatment after six months.

Eli Lilly and Company stated that it still expects to report the results of the confirmatory Phase III trial for donanemab in the second quarter of this year. The company said that this study will form the basis of donanemab's application for FDA approval.

Dr. Eric Reiman, Executive Director of the Banner Alzheimer's Institute, stated: "I don't see this as any kind of setback or delay in terms of the drug’s progress or timeline. I know that by the end of the Phase III trial, it will have safety data on at least 100 patients."

Russ Paulsen, Chief Operating Officer of the U.S. non-profit organization UsAgainstAlzheimer, expressed disappointment that the treatment drug could not serve patients sooner but was encouraged by the reason behind it. He stated, "The efficacy of donanemab is excellent. The FDA required at least 100 patients to have taken the drug for a minimum of 12 months. However, due to the rapid effect of donanemab on some patients, many were able to stop treatment within just six months."