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# Advisory Committee Aducanumab Deliberations Explained
- URL: https://www.fdaweb.com/advisory-committee-aducanumab-deliberations-explained/
- Published: 2021-03-31T12:00:00.000Z
- Updated: 2026-09-14T16:53:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149008

Three academics from different universities who participated in the 11/6/20 meeting of the FDA Peripheral and Central Nervous System Drugs Advisory Committee that considered the efficacy and safety of Biogen’s aducanumab for use in treating Alzheimer’s disease say that randomized trials should remain the primary means that regulators use to assess product efficacy. Writing in the *Journal of the American Medical Association*, the three [say](https://jamanetwork.com/journals/jama/fullarticle/2778191?ref=fdaweb.com) that patients, doctors, and policymakers rely on such tests to provide confidence in the safety and effectiveness of new therapeutics.

The article notes that Biogen conducted two Phase 3 studies that were terminated early after a planned interim analysis met pre-specified futility criteria. However, information gathered after the futility determination produced conflicting evidence of efficacy between the two studies.

The authors discuss the use of a single trial and note there has been criticism of the degree of collaboration between FDA and Biogen to analyze the pivotal trials and an earlier Phase 1b study to determine the importance of the statistically significant results in one Phase 3 trial.

Based on extensive evidence presented at the advisory committee meeting, the authors write, committee members voted to reject the idea that there was strong evidence supporting the effectiveness of aducanumab for treating Alzheimer’s disease. They say FDA will consider this advice when deciding on the Biogen NDA.