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US approves new controversial Alzheimer’s drug Business և economics news


A new drug made from live cells given by infusion reduces the plates of the brain, gives hope to the sufferers.

On Monday, U.S. health officials approved a new drug for Alzheimer’s disease, the first in 20 years, giving hope to more than 6.2 million Americans over the age of 65.2 and more people worldwide with brain disease.

On Monday, the Food and Drug Administration (FDA) announced that it had approved a drug called aducanumab for patients with Alzheimer’s disease.

It is the only regulatory drug approved by US regulators to treat the underlying cause of fat accumulation in the brain. Clinical trials of the new drug, developed by Biogen Inc., have shown plate reduction, thereby contributing to slower mental decline.

However, FDA approval of the drug is controversial due to warnings from independent experts that the treatment does not work. The FDA requires Biogen to conduct additional clinical trials to test the expected benefits of the drug.

Groups of Alzheimer’s patients and their families say that any new therapy, even one of the small benefits, will be justified.

Biogen did not immediately disclose the price, although analysts estimated that the drug could cost between $ 30,000 and $ 50,000 a year for treatment.

A preliminary analysis by the nonprofit Institute for Clinical and Economic Review found that the drug should cost between $ 2,500 and $ 8,300 a year to be a good value based on the “small general health gains” suggested by the company’s research.

The new drug is made from living cells that must be infused into a doctor’s office or hospital. The Alzheimer’s Association welcomed the decision as a historic step forward.

Researchers do not fully understand what causes Alzheimer’s, but there is general agreement that the aducanumab target brain plaque is just one factor.

Growing evidence suggests that family history, education, chronic conditions such as diabetes, and heart disease may all play a role.

“This is just part of the puzzle, I think all of these other options need to be explored and strengthened,” Dr. Ronald Petersen, a dementia specialist at the Mayo Clinic, told the Associated Press after consulting with other Biogen pharmacists. with:

In November, an external committee of neuroscientists voted “no” to a number of questions about whether data from a single study by Biogen showed that the drug was effective.

Biogen had stopped two studies Following the disappointing results of the drug in 2019, it was assumed that aducanumab, which Biogen sells as Aduhelm, would not meet its goal of slowing the mental and functional decline of Alzheimer’s patients.





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