Posted by Michael Wonder on 07 Jun 2021
ICER issues statement on the FDA’s approval of aducanumab for Alzheimer’s disease
7 June 2021 - The ICER believes that the FDA, in approving aducanumab (Aduhelm, Biogen) for the treatment of Alzheimer’s disease, has failed in its responsibility to protect patients and families from unproven treatments with known harms.
Our review of the evidence was concordant with that of many independent experts: current evidence is insufficient to demonstrate that aducanumab benefits patients.
The avenue forward has seemed clear: another study would be needed to reduce the substantial uncertainty about the drug’s effectiveness, a requirement of even greater priority because of the drug’s common and potentially serious side effects.
