Doctors Frustrated By Lack Of Guidance On Who Should Get Aduhelm

Doctors who treat patients with Alzheimer’s disease – even neurologists involved in clinical trials for Biogen, Inc./Eisai Co., Ltd.’s Aduhelm (aducanumab) – are unsure who actually should be treated with the drug and who will pay for it based on the broad label approved by the US Food and Drug Administration.

Scrip spoke with physicians who expressed frustration with the FDA’s 7 June decision to grant accelerated approval based on Aduhelm’s ability to clear amyloid plaques from the brains of Alzheimer’s patients in the Phase III EMERGE and ENGAGE clinical trials. The drug was approved for Alzheimer’s disease without limiting treatment to the population studied in those trials – patients with early Alzheimer’s disease and mild cognitive impairment (MCI), who have amyloid in their brains as confirmed by an MRI and who met other clinical assessment criteria