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FDA approves Aduhelm First Alzheimer’s drug in 20 years



A new drug for Alzheimer’s disease in nearly 20 years was approved by health officials on Monday. The decision ignored warnings from independent consultants that the highly controversial treatment has not been shown to slow brain-damaging diseases.

The Food and Drug Administration says it has approved a drug developed by Biogen for patients with Alzheimer’s disease. The drug called Aduhelm is scientifically known as aducanumab (pronounced “add-yoo-CAN-yoo-mab”).

It is the only drug that US regulators have. said that there is a tendency to treat underlying diseases Instead of managing symptoms such as anxiety and insomnia, Biogen shares jumped after the FDA announcement, up 38 percent to close at $395.85.

such a decision This could affect millions of older Americans and their families. That will certainly spark controversy among doctors. medical researcher and patient groups There are also broad implications for standards used to evaluate experimental treatments. This includes only standards that show increased benefits. The FDA said it believes the drug̵

7;s benefits for people with Alzheimer’s disease outweigh the risks.

“We are well aware of the interest in this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Ultimately, we decided to take the accelerated approval route. It is a path that is intended to provide earlier access to potentially valuable treatments for patients with critical illnesses with unmet needs.”

Biogen’s new drug co-developed with Japanese company Eisai isn’t mind-blowing. only slowing it down in one study. This medication is injected every four weeks.




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