FDA narrows indication for Aduhelm

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SILVER SPRING, Md. _ The Food and Drug Administration has narrowed the indication for Biogen and Eisai Co.’s controversial Alzheimer’s disease drug Aduhelm (aducanumab-avwa), recommending it only for patients with mild symptoms.

The FDA approved an updated label to align it with the disease stages studied in clinical trials. Approved wording includes, “Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

Dr. Alfred Sandrock, Jr., head of research and development at Biogen, said, “Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval. We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”

The FDA granted accelerated approval to Aduhelm in June, eight months after a stern rejection of the drug by an advisory committee. Within the agency, there was a lack of consensus about how to handle the drug, given ambiguous data on effectiveness.

Ultimately, the regulatory body opted for the accelerated approval as opposed to full acceptance. One of the clinical trials did not find a benefit to patients, but two others showed positive effects, regulators concluded.

Peter Stein, director of the agency’s Office of New Drugs, wrote that the FDA “is faced with a situation where the available evidence on the clinical endpoints is short of what we would require for standard approval of aducanumab. At the same time, patients with [Alzheimer’s] have a serious, progressive, ultimately fatal disease and are desperate for treatments.”


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