FDA approves first Alzheimer's drug in nearly 20 years despite controversy

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U.S. regulators on Monday approved Biogen Inc's aducanumab as the first treatment to address an underlying cause of Alzheimer's disease despite controversy over mixed clinical trial results for the drug.
In this undated image from video provided by Biogen in May 2021, vials of the medication aducanumab are handled by machines during manufacturing in Switzerland. On Monday, June 7, 2021, the Food and Drug Administration approved aducanumab, the first new drug for Alzheimer's disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn't been shown to help slow the brain-destroying disease. (Biogen via AP)

WASHINGTON (AP) — Government health officials on Monday approved the first new drug for Alzheimer's disease in nearly 20 years, disregarding 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.

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.

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 new drug, which Biogen developed with Japan's Eisai Co., did not reverse mental decline, only slowing it in one study. Named Aduhelm, the medication is is given as an infusion every four weeks.

The FDA's top drug regulator acknowledged in a statement that "residual uncertainties" surround the drug, but said Aduhelm's ability to reduce harmful clumps of plaque in the brain "is expected" to help slow dementia.

Under terms of the approval, the FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does…
Matthew Perrone/AP Health Writer
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