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Tuesday, March 28, 2023

Biogen slashes price of Alzheimer’s drug EduHelm as it faces hurdles

Biogen on Monday slashed the price of its controversial new Alzheimer’s drug EduHelm as the drug faced weak sales and mounting criticism.

The price was lowered from $56,000 to $28,200 a year on the same day that a group of Alzheimer’s experts and health advocates called on the Food and Drug Administration to remove the drug from the market, saying they filed a formal petition with it. supporting the effort. the agency taking it back.

“The FDA’s decision to approve EduHelm is unforgivable in both scientific and clinical terms,” ​​said a statement signed by 18 scientists. “This drug should be immediately withdrawn from the market.”

The agency approved EduHelm in June, even after a council of senior FDA officials, an advisory committee of outside experts and several Alzheimer’s experts said scientific evidence shows the drug did not provide a clear benefit to patients and that it was dangerous. Raises the risk of side effects.

Major health systems, including the Cleveland Clinic, Mount Sinai Health System, Mass General Brigham and the Department of Veterans Affairs, have declined to offer EduHelm, citing questions about its benefits and risks. In October, Biogen reported that EduHelm had brought in only $1.9 million in revenue through September, a surprisingly small amount considering that about 1.5 million Americans have mild Alzheimer’s-related dementia that would qualify them for the drug. Is.

In a statement about the price cuts on Monday, Biogen’s chief executive officer, Michelle Vonatsos, said the company “listened to the feedback of our stakeholders” and recognized that “not many patients are offered the choice of Eduhelme for financial reasons.” going. Thoughts.”

But Brian Skorney, an analyst at Robert W. Baird & Co., said after the price announcement: “For the wide majority of people who criticize EduHelm, both $56,000 and $28,000 are extraordinarily high prices for a drug that’s too high. From what people understand. Doesn’t work at all.”

Alzheimer’s experts and health advocates called on the FDA to withdraw EduHelm after a three-hour video meeting between scientists last week.

Peter Whitehouse, a neurologist and Alzheimer’s specialist at Case Western Reserve University who led the December 15 meeting, told attendees during the session, “We’re not just saying that approval was probably the worst decision the FDA ever made. ” “It’s so bad that we must advocate for a comeback.”

The doctors and scientists who signed the statement also agreed to provide their expertise to assist in filing the civil petition, a formal process for overturning the FDA’s decision. The petition will be filed by the Right Care Alliance, a coalition of physicians, patients, and community members, which is also circulating a pledge to physicians who promise not to prescribe EduHelm and to patients and family members. For those who say they will not request it.

President of the Right Care Alliance and president of the Lawn Institute, a health care think tank, Dr. Vikas Saini said the civil petition process could take months or even years, but it could prompt FDA action.

Dr Saini, who helped organize last week’s meeting, said that out of 45 civil petitions filed by the group Public Citizen since 1971, in 27 cases the FDA withdrew drugs from the market and in seven others the agency expedited the use of the drug. banned from.

In response to calls to withdraw approval of EduHelm, also known by its scientific name, educanumab, an FDA spokesperson said that “the data set for EduHelm was very complex, and we reviewed it thoroughly.” Has been.”

The spokesperson also said that “careful analyzes of Phase 2 and Phase 3 clinical trials support the conclusion that it is likely that EduHelm provides clinical benefit – although currently available data are not clinical.” does not provide sufficient evidence of effectiveness over benefit.”

Aduhelm is also facing resistance in other countries. On Friday, reviewers from the European Union’s drug regulator, the European Medicines Agency, recommended against approving EduHelm, a decision that Biogen said it would ask to re-examine.

Several months ago, Canada’s leading Alzheimer’s research organizations said that approving the drug in Canada “may not be appropriate.”

Dr. Howard Chertko, scientific director of the Canadian Consortium on Neurodegeneration in Aging, was one of three Alzheimer’s experts from outside the United States who signed a statement calling on the FDA to withdraw the drug. “We feel it is a breach of our responsibility as physicians to allow very high-cost marginal medicine to come into the country, so we are trying to prevent incidents in the states from happening in Canada. Quite active,” he said at last week’s meeting.

Two nearly identical clinical trials of Eduhelm, a monoclonal antibody given as a monthly infusion, were stopped early after an independent data monitoring committee concluded that the drug was not beneficial. Biogen’s later analysis found that participants who received higher doses of the drug in one trial experienced a slightly slower rate of cognitive decline, but participants in another trial did not benefit at all.

About 41 percent of patients receiving the higher dose — the FDA-approved dose — experienced brain swelling or brain hemorrhage, side effects that were often mild or asymptomatic, but sometimes severe.

Monday’s statement also raises objections to the appropriateness of the FDA’s approval. Recognizing that EduHelm would help patients, the agency flagged it under a program called “accelerated approval,” which allows the authorization of drugs without proof of benefit for critical illnesses that have few treatment options. If the drug affects part of the biology of the disease. (known as a surrogate endpoint) in a way that is “reasonably likely to predict clinical benefit.”

The FDA based its approval on EduHelm’s ability to reduce a protein called amyloid that forms plaque in the brains of people with Alzheimer’s. But experts say years of studies have not shown that reducing amyloid helps with memory or thinking problems.

At last week’s meeting, Dr. Kenneth Langa, a professor of medicine at the University of Michigan, said that approving the drug “will have enormous and widespread negative implications for patients, families” because of amyloid deficiency and dementia research.

The group’s statement, which includes a section in support of others signing their names, follows on from the FDA’s language by calling for a “quick withdrawal.”

“Reading the FDA’s rationale was like watching a ‘Saturday Night Live’ skit for data nerds,” Dr. Saini said. “I mean, I had trouble believing it.”

The agency’s approval requires that Biogen conduct another test to see if EduHelm works. In its response on Monday, an FDA spokesperson said, “We believe the data support expedited approval, holding the company accountable for conducting an additional study.” Last week, Biogen said it had developed a protocol to complete that trial in 2026, several years ahead of a deadline imposed by the FDA.

Before signing Monday’s statement, Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health, who helped organize the meeting, said that with advocacy groups like the Alzheimer’s Association still supporting approval of the drug, they should “Anxiety that asking for something might trigger a response that undoes where we really want to go.”

But Dr. Jerry Avorna, a professor of medicine at Harvard Medical School, also signed off on the statement, saying that although it was unlikely that calling for a withdrawal would cause FDA officials to say, “Yeah, they’re right, we fooled, we better undo this decision,” the action was nonetheless important. “We’re taking a stand and saying that the process was terrible and the result was terrible, and if they don’t hear it, it’s going to be a shot of sorts across the bow.”

Rebecca Robbins contributed reporting.

World Nation News Desk
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