FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials
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.
- 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 update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.
- Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies statement of June 23, 2021.
- 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.