The Food and Drug Administration (FDA) has approved an updated label for the recently approved Alzheimer’s drug Aduhelm (aducanumab) to emphasize that the anti-amyloid monoclonal antibody should be used only in patients whose Alzheimer’s disease is in early stages.
The updated label states, “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.” The original label stated only that Aduhelm was for the treatment of Alzheimer’s disease.
Just last month the FDA granted accelerated approval to the drug based on data from three clinical studies (including two phase 3 studies) that demonstrated a significantly greater reduction of amyloid beta plaques in patients with early stage Alzheimer’s disease who took aducanumab compared with those who took placebo. However, data from two phase 3 trials on the effects of aducanumab on cognition were inconclusive: One of the trials found that patients who received aducanumab had slightly slower cognitive decline than those who received placebo, but the other trial did not.
The FDA’s accelerated approval pathway is designed to speed up the approval of medications for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. The pathway enables drug companies to provide a surrogate biomarker that they believe can reasonably suggest future clinical benefit. Yet Aduhelm’s approval drew criticism because last November an FDA advisory panel voted nearly unanimously to reject the drug on the grounds that the clinical data supporting it were not sufficient to warrant approval. Since then, three of the advisory committee members who voted to reject the drug have resigned. The FDA is not obligated to follow the recommendations of its advisory committees, which are made up of outside experts.
Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003.
For related information, see the Psychiatric News article “Alzheimer’s Pipeline Edges Away From Amyloid.”
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