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Home » FDA updates label on controversial Alzheimer’s drug, saying it’s only meant for early-stage patients

FDA updates label on controversial Alzheimer’s drug, saying it’s only meant for early-stage patients

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A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use.

The Food and Drug Administration said the change is intended to address confusion among physicians and patients about who should get the drug, which has faced an intense public backlash since its approval last month.

The new drug label emphasizes that the drug, Aduhelm, is appropriate for patients with mild or early-stage Alzheimer’s, but has not been studied in patients with more advanced disease. That’s a big change from the original FDA instructions, which said simply that the drug was approved for Alzheimer’s disease in general.

Drugmaker Biogen announced the change in a release Thursday, stating that the update is intended to “clarify” the patients studied in the company trials that led to approval. The FDA first approached the company about narrowing the label and OK’d the language.

“Hearing these concerns, FDA determined that clarifications could be made to the prescribing information to address this confusion,” the agency said in an emailed statement. Despite the update, the FDA added that “some patients may benefit from ongoing treatment” if they develop more advanced Alzheimer’s.

When the drug was first approved, a top FDA official told reporters the drug was “relevant to all stages of Alzheimer’s disease.”

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