Eli Lilly: full response letter from FDA

(CercleFinance.com) - Eli Lilly announced on Thursday a complete response letter from the US FDA regarding its application for accelerated approval of donanemab for the treatment of early symptomatic Alzheimer's disease.


For the record, this request for accelerated approval was based on a phase 2 trial that showed a reduction in amyloid plaque, but with a number of patients that the US health authority deemed limited.

In its letter, the FDA specifically asked the company to provide data on at least 100 patients who received a minimum of 12 months of continuous treatment with donanemab. No other gaps in the application were identified.

A confirmatory phase 3 trial is still underway, with the first data expected to be read out in Q2 2023, which will form the basis of the traditional application for approval of donanemab shortly thereafter.


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