The FDA approved the new label, which will specify that Aduhelm should be used in patients with mild cognitive impairment or mild dementia stage of the disease, which were the populations involved in clinical trials of the drug.
“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 in a news release.
The new label specifies that “there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”
Read Biogen’s full news release here.
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