Most (54%) respondents indicated that they believe the FDA made a mistake when it approved the controversial Alzheimer’s drug in June 2021.
The dust still hasn’t settled on the FDA’s controversial decision last year to approve Biogen’s Alzheimer’s drug, Aduhelm (aducanumab). Last week CMS announced that it is proposing to cover the drug only if the patient is enrolled in an approved clinical trial, a move that seems to reflect concern the FDA’s OK was based on shaky evidence. Biogen fired off a press release said if the Jan. 11 coverage decision doesn’t change, nearly all Medicare beneficiaries will be denied access to its drug. Biogen had already tried to blunt some of the criticism of its anti-amyloid drug by slashing its price in half, from $56,000 a year, on average, to $28,200.
Most of the respondents to our annual State of the Industry are in the skeptical/critical camp when it comes to Aduhelm: 54% indicated that they believed it was a mistake for the FDA to approve the drug. The survey had 100 respondents, although not every respondent answered all the questions.
Aduhelm was approved on the FDA’s accelerated pathway, which, among other things, means a drug will be judged by the agency on its effects on surrogate markers for management or control of a disease rather than on manifestations of the disease itself. The solid majority believes the Aduhelm approval was a misstep but an even larger majority (74%) of the respondents indicated that they didn’t think the FDA has approved too many drugs through the accelerated approval process.