FDA Advisers Tear Apart Case for Biogen's Alzheimer's Drug Aducanumab Ahead of Final Decision

According to an article in JAMA , U.S. Food and Drug Administration (FDA) advisers who opposed the approval of Biogen's Alzheimer's disease drug aducanumab have restated their case before a June decision on whether to approve the medication, reports FierceBiotech . The advisers contend that post hoc analyses of the aducanumab clinical trials risk "inadvertently selecting data precisely because those data were consistent with the outcomes that were hoped for." They elaborate that the analyses do not explain why the trials had differing results, with one discontinued for futility, while the other trial's data said discontinuation was premature. Biogen claims the divergent results reflect the number of people who received the high dose and the division of patients whose condition declined rapidly. The FDA experts counter that the long history of failures of amyloid clinical trials means the difference between the aducanumab studies is "consistent" with a false positive finding. They also highlight the medication's risks based on the rate of amyloid-related imaging abnormalities (ARIA) in patients. Most ARIA cases were asymptomatic, and supporters claim the risk can be mitigated with imaging and dosing management. But the FDA advisers express doubts about "how consistently and comprehensively" mitigation could be conducted in clinical practice.