FDA changes course, limiting suggested uses for groundbreaking Alzheimer’s drug

After weathering intense criticism for approving a new drug for all Alzheimer’s patients, the U.S. Food and Drug Administration has changed course, recommending that only people with early-stage symptoms should receive it.

The updated label more closely aligns Aduhelm’s recommended usage with the patient population it was tested in during clinical trials.

The Society of Nuclear Medicine & Molecular Imaging past President Alan Packard, PhD, brought up a similar inconsistency last month, noting he was “extremely surprised” amyloid PET imaging wasn’t listed as a requirement to begin treatment given the drug’s approval was based on such scans.

Biogen revealed the label change Thursday afternoon.

“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,” the new prescribing label reads. “There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

Under the previous indication, up to six million Americans were likely eligible for treatment. That figure is now estimated to be around two million, the New York Times reported June 8. 

For the imaging community, patients will still require either an amyloid-positive PET scan or lumbar puncture to begin treatment. Baseline and periodic MRI scans are also mandatory to track disease progression.

SNMMI previously indicated it would engage in talks with the federal Centers for Medicare and Medicaid Services to ensure amyloid PET scans are required for treatment.

“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, head of Research and Development at Biogen said Thursday. “We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”

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