JUST IN: U.S. health officials on Friday approved a closely watched Alzheimer’s drug that modestly slows the brain-robbing disease, albeit with potential safety risks that patients and their doctors will have to carefully weigh.
The Food and Drug Administration approved it for patients with Alzheimer’s, specifically those with mild or early-stage disease.
The FDA approval came via its accelerated pathway, which allows drugs to launch based on early results, before they’re confirmed to benefit patients. The agency’s use of that shortcut approach has come under increasing scrutiny from government watchdogs and congressional investigators. Some 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and daily tasks.
There is little consensus on whether that difference translates into real benefits for patients, such as greater independence. “Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience?” he asked. “I have pretty serious doubts.” A key question in the drug’s rollout will be the coverage decision by Medicare, the federal health plan that covers 60 million seniors and other Americans. The agency severely restricted coverage of Aduhelm, essentially wiping out its U.S. market and prompting Biogen to abandon marketing plans for the drug.
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