FDA narrows label for Biogen’s Alzheimer’s drug
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A drug hailed as a possible breakthrough in treating Alzheimer's will now be available to fewer people. Pharmaceutical giant Biogen said on Thursday it is updating the label on its Aduhelm medication after the U.S. Food and Drug Administration approved changes to the product information.
The new label will effectively narrow the target population. It’ll say that treatment should be initiated in patients with mild cognitive impairment or mild dementia.
It will also say there was no safety or effectiveness data on initiating treatment at earlier or later stages of the disease.
When the FDA approved the drug last month, it did not restrict its use to a specific group of patients. The agency’s speedy approval sparked controversy as critics questioned the strength of the trial data. The drug had been studied in patients at an early stage of the disease.
More than 6 million Americans currently suffer from Alzheimer’s, and that number is expected to more than double by 2050, according to the Alzheimer’s Association. It’s the sixth leading cause of death in the U.S.
News of the updated label sent Biogen shares down more than 3% in early trading Thursday.
