The FDA plans to convene a Central and Peripheral Nervous System Drug Advisory Committee meeting to discuss Eli Lilly and company LLY Phase 3 TRAILBLAZER-ALZ 2 study, which evaluated the efficacy and safety of donanemab in symptomatic early Alzheimer’s disease.
The FDA has advised Lilly that it intends to further investigate the safety and efficacy evaluation of donanemab, including the safety outcomes in patients treated with donanemab and the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study, including its limited-duration dosing regimen that allowed patients to complete treatment based on an amyloid plaque assessment and inclusion of participants based on tau levels.
The Donanemab Advisory Committee meeting date has yet to be set by the FDA, and as a result, the timing of the FDA’s expected action on donanemab will be delayed beyond the first quarter of 2024.
While it is unusual for an advisory committee to meet after the FDA’s expected action date, the advisory committee meeting for donanemab follows similar meetings for the other two FDA-approved amyloid plaque-targeting therapies.
“We are confident in donanemab’s potential to provide very significant benefits to people with symptomatic early Alzheimer’s disease. It was unexpected to learn that the FDA will convene an advisory panel at this stage of the review process, but we look forward to the opportunity to further present the results of TRAILBLAZER-ALZ 2 and put donanemab’s strong efficacy in the context of safety,” said Anne White, executive vice president of Eli Lilly and president of Lilly Neuroscience.
Biogen Inc BIB stocks are trading higher in reaction to the FDA delaying its decision on Eli Lilly’s Alzheimer’s drug.
Donanemab would compete Eisai Co Ltd ESALY/Biogen’s Leqembi, for which the FDA granted standard clearance last year.
Read next: Analysts say Eli Lilly’s Donanemab in Alzheimer’s is encouraging, and outline potential implications for the biogen.
Price Action: LLY shares fell 0.64% to $775.16, while BIIB shares rose 3.73% to $227.55 in the pre-market session at last check on Friday.
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