Fallout continues on from the Food and Drug Administration’s controversial decision this week to approve Biogen̵7;s Alzheimer’s drug Aduhelm (aducanumab), although no efficacy data is available.
Three experts who sit on the FDA’s advisory committee have resigned from the decision.
The advisory board reviewed the data behind Aduhelm last November. And an overwhelming vote opposed the approval. The panel’s 11 advisors, 10 of whom voted “no” on the question of whether Biogen had gathered enough evidence to indicate the drug was effective. The rest of the advisers voted “uncertain”.
However, the FDA approved the drug on Monday. Although regulators are aware that there are “Uncertainty about [the] “Clinical Benefits” of Aduhelm, the FDA said it decided to reduce the requirements for approval after an advisory panel voted. Instead of using the drug’s efficacy approval Residency In this case, an agent is the drug’s ability to reduce amyloid beta plaque in the brains of some Alzheimer’s patients.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, wrote in a statement this week: “A reduction in plaque is likely to result in clinical benefit.”
The approval and explanation angered advisory board members, Aaron Kesselheim, a professor at Harvard Medical School who is also director of Program On Regulation, Therapeutics and Law at Brigham and Women’s Hospital, in a resignation letter to Janet. Woodcock, acting FDA commissioner on Thursday. Kesselheim called the FDA decision “probably the worst drug approval decision in recent US history.”
He noted that the advisory board did not mention the surrogate endpoint—in fact, he noted that the FDA specifically told the committee not to use beta-amyloid plaque washing as a substitute for efficacy.
Kesselheim also criticized other aspects that the FDA oversaw the board meeting, writing:
at a public meeting Concerns about experimental data from one of the FDA reviewers did not provide enough time for discussion. And some of the questions the FDA asked the committee to answer were worded in a skewed manner in order to get a favorable answer. drug approval
Overall, he described the decision as a failure and wrote, “It is clear to me that the FDA is currently unable to adequately incorporate the committee’s scientific recommendations into its approval decision.” out of the committee, which he has Service since 2015
In his resignation, he joined neurologists David Knopman of the Mayo Clinic in Minnesota and Joel Perlmutter of Washington University in St. Louis, who also announced their retirements this week.
As for the rest of the questions about Biogen’s Aduhelm efficacy, the FDA is requiring Biogen to conduct another clinical trial to assess the drug’s efficacy. If a company doesn’t identify the drug as effective, the FDA may revoke its approval. However, Biogen has up to nine years to submit the information. throughout that period Drugs can be prescribed to patients at a list price of $56,000.
In an interview with Axios released Friday, Maha Radhakrishnan Biogen’s Chief Medical Officer answers the question why the company hasn’t just started more trials. Given the apparent uncertainty in the data seen long ago in 2019, Radhakrishnan said the FDA was not asking the company to take action to obtain approval.