Accelerated Approval Denied for Donanemab

Following on the heels of the Food and Drug Adminstration’s (FDA) approval of Lequembi (lecanemab) to treat Alzheimer disease (AD), the agency declined accelerated approval of donanemab (LY3002813; Eli Lilly and Company, Indianapolis, IN). Details available in the complete response letter issued by the FDA indicate that an insufficient number of patients with 12-month drug exposure data were included in the submission; no other deficiencies were noted by the FDA. The accelerated approval application included data from the TRAILBLAZER-ALZ phase 2 clinical trial (NCT03367403) which showed improvements in cognitive scores and reductions in amyloid plaque levels and global tau loads in participants assigned to treatment with donanemab compared with participants assigned to a placebo. 

According to a statement issued by Eli Lilly, “We look forward to our upcoming confirmatory phase 3 results and subsequent FDA submission, which we've always seen as the most impactful next steps for patients. 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." 

Donanemab along with Lequembi and Aduhelm represent humanized immunoglobulin gamma 1 (lgG1) monoclonal antibodies which are directed against forms of amyloid beta for the treatment of AD.