The F.D.A.’s decision to green-light it, announced Monday, marked the first approval of an Alzheimer’s treatment in 18 years.
But since at least last fall, several respected experts, including some Alzheimer’s doctors who worked on the aducanumab clinical trials, have said the available evidence raised significant doubts about whether the drug is effective.
Beyond their conviction that the existing evidence for Aduhelm’s benefit is weak, the advisory committee members who resigned — as well as several prominent Alzheimer’s experts — objected to two major aspects of the F.D.A.’s approval decision.
approved the drug for a much broader group of patients — anyone with Alzheimer’s — than many experts were anticipating.
The clinical trials tested the drug only on patients with early-stage Alzheimer’s or mild cognitive impairment from the disease.
Kesselheim, —, ’, Alzheimer’s