FDA rejects early approval for Lilly’s Alzheimer's drug

The US FDA has declined to grant Eli Lilly accelerated approval of monoclonal antibody drug, donanemab.

Eli Lilly said the complete response letter (CRL) received from the US Food and Drug Administration (FDA) has been issued due to the limited number of patients with at least one year of drug exposure data provided in the application and stated that no other deficiencies have been identified.

The FDA specifically requested that Lilly provide data from a minimum of 100 patients who received 12 months of treatment of humanized IgG1 monoclonal antibody donanemab (LY3002813). The firm claims the trial did include over 100 patients, but the speed of plaque reduction resulted in multiple patients being able to stop dosing within six months of treatment, resulting in less than 100 patients receiving one year of donanembab.

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According to Lilly, the FDA pointed out that the data to meet the exposure requirement would most likely need to contain the unblinded controlled safety data from clinical trial design TRAILBLAZER-ALZ 2 upon completion.

Phase III of the TRAILBLAZER-ALZ 2 trial is ongoing and the company anticipates data read-out to be delivered in the second quarter of this year, which will then be used as the basis of donanemab’s application for approval after.

“We look forward to our upcoming confirmatory TRAILBLAZER-ALZ 2 Phase III results and subsequent FDA submission, which we’ve always seen as the most impactful next steps for patients,” said Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly.

“We anticipate this study will confirm the benefit and safety profile we observed in the TRAILBLAZER-ALZ Phase II study and believe that patients and physicians will be well served by having the full Phase III data available alongside our Phase II data when they need to make treatment decisions.”

This month, Eisai received accelerated approval for Leqembi (lecanemab), an Alzheimer’s disease drug that will be priced at $26,500 per year, roughly half the original price of Biogen’s controversial drug Aduhelm (aducanumab).