The US Food and Drug Administration (FDA) has approved an updated label for the controversial Alzheimer's drug aducanumab (Aduhelm), emphasizing that the drug should only be used in patients with the earliest stages of disease — the group studied in the clinical trials.
The FDA approved aducanumab in early June amid significant controversy and disregarding the recommendation by its own advisory panel not to approve the drug, as reported by Medscape Medical News.
The original prescribing information implied that the drug — which is administered intravenously and costs around $56,000 a year — could used for treatment of any patient with Alzheimer's disease.
The updated label now states that aducanumab should be initiated only in patients with mild cognitive impairment (MCI) or mild dementia stage of disease — the population in which treatment was initiated in the clinical trials leading to approval of the anti-amyloid drug.
The FDA granted accelerated approval of the drug based on data from clinical trials showing a reduction in amyloid beta plaques observed in patients with MCI or mild dementia stage of disease.
"Continued approval for the indication may be contingent upon verification of clinical benefit in confirmatory trial(s)," the label states.
It emphasizes that there are no safety or effectiveness data on starting aducanumab treatment at earlier or later stages of the disease than were studied.
"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," Alfred Sandrock Jr, MD, PhD, Biogen's head of research and development, said in a statement announcing the label update.
"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 Sandrock.
Full prescribing information for aducanumab is available online.
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Cite this: FDA Updates Label for Controversial Alzheimer's Drug Aducanumab (Aduhelm) - Medscape - Jul 08, 2021.