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FDA narrows label for Biogen’s Aduhelm to only include mild forms of Alzheimer’s disease

Reflects the patient population included in clinical trials of anti-amyloid treatment

The US Food and Drug Administration (FDA) has narrowed the label for Biogen’s recently approved drug Aduhelm to only include Alzheimer’s disease patients with mild cognitive impairment or mild dementia.

The FDA initially approved Aduhelm (aducanumab) for the treatment of all patients with Alzheimer’s disease, despite clinical trials only evaluating the anti-amyloid antibody in patients with milder forms of the disease.

When the FDA authorised Biogen’s drug, it highlighted that treatment with Aduhelm led to significant dose- and time-dependent reduction of amyloid beta plaque, compared to patients in the control group who had no reduction of amyloid beta plaque.

However, following criticism from experts in the field, the FDA has updated the label to specifically include only 'patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials'.

“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,” said Alfred Sandrock, head of research and development at Biogen.

The FDA approved Aduhelm via its accelerated approval pathway, which requires Biogen to conduct a new randomised, controlled clinical trial to verify the drug’s clinical benefit for Alzheimer’s patients.

The broad label was met with intense criticism, including from US cost-effectiveness watchdog ICER, that commented: “Our review of the evidence was concordant with that of many independent experts: current evidence is insufficient to demonstrate that aducanumab benefits patients.

“The avenue forward had seemed clear: another study would be needed to reduce the substantial uncertainty about the drug’s effectiveness, a requirement of even greater priority because of the drug’s common and potentially serious side effects.”

Following its surprise approval in June, Biogen announced that it would price Aduhelm at $56,000 per year of treatment.

However, in a revised report of the cost-effectiveness of the Alzheimer’s treatment, ICER said that its analysis would put the price of the drug at around $3,000 to $8,400 per year of treatment. This reflects a discount of 85-95% on the drug’s current list price.

Article by
Lucy Parsons

9th July 2021

From: Regulatory



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