Approval of Biogen’s Alzheimer’s drug reignites the “amyloid” debate

The approval of Biogen’s Alzheimer’s drug has rekindled investor interest in a controversial hypothesis of the cause of the disease, despite years of failure in the field and many scientists and doctors firmly refuted the theory.

Biogen $56,000 per year of medication It is the first approved treatment for Alzheimer’s disease in nearly two decades Green light U.S. regulators last month. It is called aducanumab and is the first treatment designed to slow down the rate of cognitive decline, rather than helping patients control their symptoms.

The drug is around Amyloid hypothesis, Its supporters believe that protein clumps that accumulate in the brain can cause Alzheimer’s disease. Biogen said that this drug can remove amyloid plaques in the brain, thereby changing the course of the disease.

The amyloid hypothesis is divided, and some scientists believe that there is little evidence that removing plaque will slow the development of Alzheimer’s disease.

Alberto Espe, professor of neurology at the University of Cincinnati, said that “in fact every study we did” proved the amyloid hypothesis, but it “survived all the evidence to the contrary.” .

Several pharmaceutical companies, including Merck and Johnson & Johnson, have tried to prove that removing amyloid plaques is directly related to improving cognition, but failed to prove it. But drugmakers persisted, attracted by the huge market and patients with few effective treatments. About 35 million people worldwide suffer from Alzheimer’s disease, and about 6 million of them are in the United States.

When the U.S. Food and Drug Administration approved aducanumab, it stated that it was only “Very likely“The treatment will show clinical benefit for patients.

Nonetheless, the FDA’s decision has rekindled interest in the field of Alzheimer’s disease research and brought hope to other pharmaceutical companies that have spent billions of dollars seeking similar treatments.

Espay added: “The FDA approval will stimulate further investment in a hypothesis that should have been falsified long ago.”

Last week, the regulatory agency granted breakthrough designations for two new trial-phase amyloid-clearing drugs, which means that the agency will accelerate their development and approval review.

Eli Lilly, the US pharmaceutical company, said it will apply for approval of its drug donanemab before the end of this year. The announcement made its stock price up 9%.

Japanese drug maker Eisai and Biogen have jointly developed aducanumab and its latest Alzheimer’s disease drug lecanemab, and it is also keen on this field of research without being influenced by the opposition.

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

“Of course I think… the FDA’s decision will reignite investment in amyloid therapy and other Alzheimer’s disease therapies,” he said, adding: “We firmly believe that the deep removal of amyloid will affect these The patient’s disease progression has a positive impact. If they are treated early enough.”

Although it is too early to judge whether funds are pouring into new anti-amyloid treatments, both parties believe that the FDA’s decision will stimulate investment in the field and encourage drugmakers to ignore historic failures and try to get a piece of it. soup. It is estimated that the US alone is a market worth billions of dollars.

Swiss drugmaker Roche is also currently experimenting with a treatment for this disease. Bernstein analysts predict that if all the company’s drugs are approved by the FDA, in the long run, Eli Lilly, Biogen and Roche will account for 50%, 30%, and 20% of the Alzheimer’s treatment market, respectively. Share.

“History does show that FDA actions, such as the approval of aducanumab, often lead to greater investment,” said Rebecca Edelmayer, senior director of scientific engagement at the Alzheimer’s Association.

Others worry that treatments that focus on removing amyloid will divert people’s attention from research on other treatments for Alzheimer’s that may be more effective.

“It takes capital to bring research results to patients. When all the large sums of money are spent on amyloid-related things, how will we raise funds?” asked George Perry, professor of neurobiology at the University of Texas at San Antonio .

He said that it may promote the development of amyloid-clearing drugs, which will not help the meaningful development of Alzheimer’s research. And “the best case scenario is that all these companies will get approval and then start researching other things.”

Analysts expect Biogen to obtain peak annual sales of up to $10 billion from aducanumab. Although two House committees said they will investigate the approval and price of the drug, the company’s stock price remains at a two-year high.

“Investors should not view the approval of aducanumab as a test of the amyloid hypothesis,” Espay said. “This is a brilliant but not science-based corporate strategy success.”

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