The price of Aduhelm was slashed by Biogen on Monday as the drug faces weak sales and mounting criticism.
On the same day that a group of Alzheimer's experts and health advocates called on the Food and Drug Administration to pull the drug off the market, the price of the drug was reduced to $28,200 a year.
The F.D.A.'s decision to approve Aduhelm is indefensible in both scientific and clinical terms according to a statement signed by 18 scientists. This drug should be taken off the market.
Aduhelm was approved by the agency despite the fact that the drug did not provide a clear benefit to patients and that it carried risks of dangerous side effects.
Cleveland Clinic, Mount Sinai Health System, Mass General Brigham and the Department of Veterans Affairs have all declined to offer Aduhelm due to questions about its benefits and risks. In October, Biogen reported that Aduhelm had brought in just $1.9 million in revenue through September, a small amount given that about 1.5 million Americans have mild Alzheimer's-related dementia.
In a statement about the price-cutting on Monday, Biogen's chief executive officer said the company had listened to the feedback of its stakeholders and believed that "too many patients are not being offered the choice of Aduhelm due to financial reasons."
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Brian Skorney, an analyst at Robert W. Baird & Company, said after the price announcement that Aduhelm is expensive for a lot of people.
The statement from Alzheimer's experts and health advocates calling on the F.D.A. to withdraw Aduhelm grew out of a three-hour video meeting among the scientists last week.
The approval was the worst decision the F.D.A. has ever made, according to Dr. Peter Whitehouse, who led the meeting. It is so bad that we should advocate for withdrawal.
The doctors and scientists who signed the statement agreed to support the filing of a citizen petition to overturn the F.D.A. decision. The Right Care Alliance is a coalition of clinicians, patients, and community members who will be filing a petition to stop Aduhelm from being prescribed.
The citizen petition process can take months or years, but it can prompt F.D.A. action, according to Dr. Vikas Saini, chairman of the Right Care Alliance and president of the Lown Institute.
In 27 cases the F.D.A. withdrew drugs from the market and in seven other cases the agency restricted the use of drugs, according to Dr. Saini.
The data set for Aduhelm was very complex, and the F.D.A. review has been thorough.
The data currently available do not provide substantial evidence of effectiveness on clinical benefit, but the analyses of the Phase 2 and Phase 3 clinical trials support the conclusion that Aduhelm provides clinical benefit.
Aduhelm has encountered resistance in other countries. The European Medicines Agency recommended against approving Aduhelm, a decision that Biogen said it would ask to be re-examined.
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Aduhelm is given as a monthly injection. In clinical trials, 41 percent of patients receiving the F.D.A.-approved higher dose experienced brain swelling or brain bleeding, often mild, but serious in some cases.
Leading Canadian Alzheimer's research organizations have said that approving the drug in Canada cannot be justified.
Dr. Howard Chertkow is the scientific director of the Canadian Consortium on Neuroscience in Aging, and he was one of three Alzheimer's experts from outside the United States who signed the statement calling on the F.D.A. to withdraw the drug. He said last week that they were trying to block what had happened in the US from happening in Canada.
The trials of Aduhelm, a monthly injection of a monoclonal antibody, were stopped early because the data monitoring committee concluded that the drug didn't appear to be beneficial. A later analysis by Biogen found that participants in the high dose trial had slowed cognitive decline, but not as much as those in the low dose trial.
Some patients who received the high dose experienced brain swelling or brain bleeding, but were often mild.
The statement objects to the F.D.A. justifying its approval. The agency greenlighted Aduhelm under a program called accelerated approval, which allows authorization of drugs without proof of benefit for serious diseases that have few treatment options if the drug affects part of the disease's biology.
The F.D.A. approved Aduhelm because it was able to reduce the amyloid in the brains of people with Alzheimer's. Years of studies have not shown that reducing amyloid helps memory or thinking problems.
Dr. Kenneth Langa, a professor of medicine at the University of Michigan, said last week that if the drug is approved, it will have huge and wide-ranging negative implications for patients, families and dementia research.
The group's statement plays on the F.D.A.'s language by calling for accelerated withdrawal.
The justification of the F.D.A. was like watching a skit for data nerds. I had trouble believing it.
The approval requires Biogen to conduct another trial to see if Aduhelm works. The F.D.A. believes that the data support accelerated approval while holding the company accountable for conducting an additional study. The F.D.A.imposed deadline for completing that trial was several years before Biogen said it had developed a protocol.
Dr. Sam Gandy, director of Mount Sinai's Center for Cognitive Health, who helped organize the meeting, said that he had a concern that advocacy groups like the Alzheimer's Association still supported the drug's approval.
Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who also signed the statement, said that calling for withdrawal was unlikely to make F.D.A. officials say, "Yeah, they're right, we goofed, we better undo this." We are taking a stand and saying the process was terrible and the outcome was terrible, and even if they don't listen to it, it will be a shot across the bow.
Rebecca Robbins was involved in reporting.
