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The FDA approves Aduhelm, the first new drug for Alzheimer’s disease in 20 years



The first new drug for Alzheimer’s disease in nearly 20 years was approved by state health officials on Monday. The decision ignores the warnings of independent advisers that the much-discussed treatment has not been shown to help slow brain-destroying disease.

The Food and Drug Administration has said it has approved a drug developed by Biogen for patients with Alzheimer’s disease. The medicine, known as Aduhelm, has the scientific name aducanumab (pronounced ‘add-yoo-CAN-yoo-mab’).

It is the only drug that US regulators say can cure the underlying disease instead of managing symptoms such as anxiety and insomnia. Shares of Biogen jumped after the announcement of the FDA, rising 38% to $ 395.85.

The decision, which could affect millions of elderly Americans and their families, is sure to spark disagreements between doctors, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only additional benefits. The FDA says it believes the benefits of the drug for people with Alzheimer̵

7;s disease outweigh the risks.

“We are aware of the attention associated with this approval,” said Dr. Patricia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “Ultimately, we decided to use the accelerated approval pathway – a pathway designed to provide earlier access to potentially valuable therapies for patients with serious illnesses when there is an unmet need.”

The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse the mental decline, but only slowed it down in one study. The drug is given as an infusion every four weeks.




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