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Biogen Alzheimer’s drug approval renews ‘amyloid’ debate

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The approval of Biogen’s Alzheimer’s drug has rekindled investors ’interest in a contested hypothesis about what causes the disease, despite years of failures in the field and the firm’s dismissal of the theory by many scientists and doctors.

Biogen’s $ 56,000 per drug per year it was the first Alzheimer’s treatment in nearly two decades to be diagnosed green light by the U.S. regulator last month. Called adducanumab, it is the first treatment that aims to slow the pace of cognitive decline, rather than helping patients manage symptoms.

The drug is conceived around the amyloid hypothesis, who claim that they believe that the protein cells accumulated in the brain cause Alzheimer’s. Biogen says the drug removes amyloid plaques from the brain and in turn alters the course of the disease.

The amyloid hypothesis is divisive, with some scientists arguing that there is little evidence that plaque removal slows the development of Alzheimer’s.

Alberto Espay, a professor of neurology at the University of Cincinnati, said that “literally every study we did” disproved the amyloid hypothesis but nonetheless it “survived all evidence to the contrary.”

Many pharmaceutical companies including Merck and Johnson & Johnson have tried and failed to demonstrate that amyloid plaque cleansing is directly linked to improved cognition. But drug manufacturers have persevered, attracted by the vast size of the market and patients facing few effective treatments. About 35 million people worldwide live with Alzheimer’s disease, with about 6 million of those in the United States.

In its approval of adducanumab, the Food and Drug Administration said it was alone.reasonably probable“That treatment will show a clinical benefit for patients.

Despite this, the FDA’s decision has rekindled interest in this area of ​​Alzheimer’s research and offered hope to other pharmaceutical companies that have spent billions to follow similar treatments.

“FDA approval will stimulate more investment in a hypothesis that should have been falsified some time ago,” Espay adds.

Last week, the regulator gave two new stage trials for the release of amyloid drugs, meaning their development and approval reviews will be accelerated by the agency.

American pharmaceutical company Eli Lilly has said it will ask for approval of its drug, donanemab, later this year, an announcement that sent its shares to 9%.

Japanese manufacturer Eisai, which has teamed up with Biogen for both adducumumin and its latest Alzheimer’s medicine, lecanemab, is also pursuing this area of ​​research, unthinkable by the opposition.

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“We have always believed that the amyloid pathway is a definite, underlying pathology for Alzheimer’s disease,” Ivan Cheung, president of Eisai, told the Financial Times.

“I certainly think that… The FDA decision will reconsider investments not only in amyloid therapies but also in other therapies for Alzheimer’s disease,” he said, adding, “We firmly believe that deep amyloid elimination will have a positive impact in terms of disease progression for these patients if they are treated early enough ”.

While it remains too early to see if the money will flow into new anti-amyloid treatments, those on both sides of the argument believe the FDA decision will stimulate investment in the area and encourage drug manufacturers to ignore the failures. historians in attempts to take a slice of the market, which is estimated to be worth billions in the United States alone.

Swiss pharmacist Roche is also currently in the process of treating the disease. Bernstein analysts expect Eli Lilly, Biogen and Roche to reach, respectively, 50, 30 and 20 percent of the Alzheimer’s treatment market, if all of the companies ’drugs are FDA-approved.

“History has really shown that FDA actions such as approving dopanumab are often likely to lead to a larger investment,” said Rebecca Edelmayer, senior director of scientific engagement at the Alzheimer’s Association.

Others are concerned that the focus on amyloid cleansing treatments will draw attention from research into other Alzheimer’s treatments that might be more effective.

“To take research results and bring them into patients involves having capital. How will we be able to raise money when all the big money will be on amyloid-related things?” Asked George Perry, a professor of neurobiology at the University of Texas San Antonio.

He said the likelihood of boosting amyloid cleansing drugs would do nothing to significantly develop Alzheimer’s research. and that “the best-case scenario is that all of these companies will receive approval and then go in search of other things.”

Analysts expect Biogen to collect up to $ 10 billion in peak annual sales from adducanumab and the company’s shares will remain at a two-year high despite two House committees saying they will invest in the approval and price of the drug.

“The approval of addanuumab should not be seen by investors as a validation of the amyloid hypothesis,” Espay said. “This is the success of a corporate strategy that was brilliant but was not based on science.”


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