(CNN) The US Food and Drug Administration has narrowed the group of Alzheimer's disease patients who should receive the controversial drug aducanumab, sold as Aduhelm. The FDA approved changing the drug's label to clarify that the treatment is intended specifically for patients with mild cognitive impairment or milder stages of disease, according to an announcement Thursday from the companies Biogen and Eisai. "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 new prescribing information states. Initially, the previous prescribing information for the drug -- which was approved by the FDA last month -- noted that aducanumab is indicated to treat Alzheimer's disease but did not specify a certain stage of the disease.

Source: CNN July 08, 2021 20:26 UTC