An influential, independent panel unanimously voted that aducanumab (Aduhelm) offers no benefit for patients with Alzheimer's disease (AD), adding to growing opposition from medical experts to the US Food and Drug Administration's (FDA's) approval of this controversial drug.
The Institute for Clinical and Economic Review (ICER) asked one of its expert panels, the California Technology Assessment Forum, to consider the available data about aducanumab and requested that members vote on whether there was sufficient evidence of a net benefit of aducanumab plus supportive care vs supportive care alone. All 15 panelists voted no.
Several panelists as well as ICER President Steven D. Pearson, MD, talked about their personal experience with family members who have the disease.
There was universal agreement among the panelists that there is an urgent need for effective medications to treat the disease. However, the panel of clinicians and researchers also agreed that the evidence to date does not show that the drug helps patients with this debilitating disease.
Panelist Sei Lee, MD, a geriatrician at the University of California, San Francisco, said he lost his mother to AD 6 years ago. In addition to his clinical work, Lee has conducted research focused on improving the targeting of preventive AD interventions for older adults to maximize benefits and minimize harms.
