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FDA Narrows Suggested Uses for New Alzheimer’s Drug

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U.S. health regulators narrowed the prescribing instructions for the first new Alzheimer’s drug in nearly two decades, recommending the therapy be given to people with early-stage symptoms of the disease.

The change recommends use of the drug, Aduhelm from Biogen Inc., be brought in line with the patients it was studied in.

It could also make it easier for Medicare, the federal insurance program that is expected to pay for most prescriptions, to limit the bill it faces from Aduhelm in coming years by restricting the number of patients who take it. Biogen disclosed the label change Thursday.

The U.S. Food and Drug Administration, which made the change, initially approved Aduhelm in June for all Alzheimer’s patients, rather than the specific group of patients with relatively mild symptoms for whom the drug was designed.

Some doctors and health economists criticized the broad approval, warning it could drive up wasteful Medicare spending by prompting sicker patients to take the medicine despite unlikely benefit.


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