Society Expresses Concern to FDA on Labeling of Aducanumab
Last week, the Society joined the American Geriatrics Society, the Society of General Internal Medicine, and the Society of Nuclear Medicine and Molecular Imaging, in writing a letter to the Food and Drug Administration (FDA) expressing concern for its label for the dispensing of aducanumab for patients with mild cognitive impairment (MCI) and Alzheimer’s disease (AD). The groups stated that the labeling differs significantly from what was studied in the Phase III clinical trials because the FDA-approved indications for use include a much wider range of patients than were studied.
Specifically, the groups said that the revised label fails to clearly note that aducanumab was used for treatment of generally healthy patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease with confirmed presence of amyloid plaque, the population in which treatment was initiated in clinical trials. “The label does not require a PET scan be performed before aducanumab can be prescribed even though all patients in the clinical trials were required to have a positive beta amyloid PET scan,” stated the letter. “The label requires MRIs be performed to identify amyloid-related imaging abnormalities (ARIAs) due to cerebral microhemorrhages and cerebral edema. In the clinical trial, patients with ARIAs had aducanumab use suspended until they resolved but the label contains no such requirement for suspension when ARIAs are identified.”
The groups further state that the label does not list any contraindications even though aducanumab was only studied in generally healthy patients. The groups ask that the label fully inform people living with Alzheimer’s disease about who was excluded from the aducanumab clinical trials since no safety and efficacy data is available for this population.