FDA approves Aduhelm, first new drug for Alzheimer's in 20 years

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Biogen's drug has aroused concerns, with some experts saying it isn't proven to slow the disease.
The first new drug for Alzheimer's disease in nearly 20 years received approval from government health officials on Monday. The decision disregarded warnings from independent advisers that the much-debated treatment hasn't been shown to help slow the brain-destroying disease.

The Food and Drug Administration said it granted approval to the drug developed by Biogen for patients with Alzheimer's disease. The drug, known as Aduhelm, has the scientific name aducanumab (pronounced "add-yoo-CAN-yoo-mab").

It's the only drug that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia. Biogen shares soared after the FDA announcement, climbing 38% to close at $395.85.

The decision, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits. The FDA said it believed the benefits of the drug for people with Alzheimer's disease outweighed the risks.

"We are well-aware of the attention surrounding this approval," Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said in the statement. "We ultimately decided to use the Accelerated Approval pathway — a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need."

We recognize the unmet medical need for patients with Alzheimer's disease, the devastating nature of the disease for patients and their families, and the urgency to make treatment available. — U.S. FDA (@US_FDA) June 7, 2021

The new drug, which Biogen developed with Japan's Eisai Co., did not reverse mental decline, only slowing it in one study.…
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