FDA Committee Does Not Recommend Approval of Aducanumab for Alzheimer Disease

A final vote that assessed whether the findings from the EMERGE trial served as primary evidence for the efficacy of aducanumab in Alzheimer disease was 10–0 that the trial did not provide evidence.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted not to recommend regulatory approval of Biogen's aducanumab, in one of the most anticipated advisory committee decisions of the year.1 In the final vote, which assessed whether or not the findings from the EMERGE trial served as primary evidence for the effectiveness of aducanumab in Alzheimer disease, the committee voted 10—0 (10 no; 0 yes; 1 uncertain) that the trial did not provide such evidence.

The committee voted 8—1 (8 no; 1 yes; 2 uncertain) that the phase 3 EMERGE study (NCT02484547) in patients with mild Alzheimer disease was enough to demonstrate efficacy. Additionally, the group voted 7–0 (7 no; 0 yes; 4 uncertain) that the prior phase 1 study, PRIME (NCT01677572), demonstrated supporting evidence of efficacy. As for the presence of strong evidence of the therapy’s pharmacodynamic effect on Alzheimer, the committee voted 5–0 (5 no; 0 yes; 6 uncertain).

In the final slide of the statistical review of aducanumab, the committee summarized that “at best, the evidence in this application is from [EMERGE] only and there exists compellingly conflicting phase 3 evidence,” noting that the approval of aducanumab could present challenges for other candidate therapies with regard to noninferiority, as well as issues with recruitment and retention for ongoing trials.

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