The majority of staffers and executives in the biotech and pharmaceutical industries disapprove of the FDA's approval of Biogen's Alzheimer's drug aducanumab, according to survey results released June 9 by Endpoints News.
The FDA on June 7 approved aducanumab, branded under the name Aduhelm, marking the first approval the agency has granted to an Alzheimer's disease treatment since 2003. The drug is the first treatment approved by the FDA to slow cognitive decline from Alzheimer's, as the Alzheimer's drugs the FDA has previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.
The FDA cleared aducanumab using its accelerated approval pathway, which is used when a treatment's approval would provide earlier access to treatments for patients with serious diseases where there is an unmet need. The drug's approval has been a prevalent topic among the medical community, media and families of Alzheimer's patients.
After the approval was announced, Endpoints News surveyed its readers, which consist mostly of workers in the biotech and pharmaceutical industries, about the decision. The outlet collected more than 1,400 responses and found that 80 percent of respondents disagree with the decision. Fifteen percent agreed, and 5 percent were on the fence.
Some of the main criticisms respondents expressed were safety concerns, the lack of conclusive efficacy data, the rapid timeline for completing the drug's clinical trial and the $56,000 annual list price, which will allow Biogen to collect billions of dollars in revenue.
When aducanumab's approval was announced, the FDA said it will continue to monitor the drug as patients begin to take it, as well as require Biogen to conduct a post-approval clinical trial to verify its clinical benefits.