The US Food and Drug Administration (FDA) announced on June 7, 2021, the approval of aducanumab (Aduhelm). The drug was approved under the Accelerated Approval pathway, one of the alternative drug approval pathways.
In addition to our latest articles on Alzheimer disease, Neurology has included a list of aducanumab resources on this page to help our members stay informed on the current landscape of the new Alzheimer disease drug.
Aducanumab: Making Sense of the Cents
Gregory S. Day, MD, MSc, MSCI, FAAN
Inevitably, the assumptions that guide cost-effectiveness calculations for any one patient will be as diverse and unique as the patient in question. Thus, we must be prepared to guide our patients with early symptomatic AD in this decision-making process, helping them to weigh uncertain benefits, risks, and costs associated with the use of aducanumab and other forthcoming treatments for AD. [Read Article]
Practical Considerations in the Administration of Aducanumab for the Neurologist
Katherine Coerver, Melissa M Yu, Anelyssa D'Abreu, Marc Wasserman, Kavita Nair
The decision by the FDA to approve aducanumab remains controversial and its administration will pose many challenges that will be new to neurologists, despite extensive experience with prior intravenous medications. [Read Article]
Decisions With Patients and Families Regarding Aducanumab in Alzheimer Disease, With Recommendations for Consent: AAN Position Statement
Winston Chiong, Benjamin David Tolchin, Richard J. Bonnie, et al.
Neurologists, patients and families will face ethical challenges given the incomplete data available to guide aducanumab prescribing, the prospect of worrisome financial conflicts of interest, and the costs and practical burdens that using aducanumab will impose on patients and families. Neurologists facing these challenges will be guided best by established ethical principles that they can apply, in turn, to transparently counsel patients and their families. [Read Article]
Aducanumab for Dementia
Brian C. Callaghan
In contrast to the unknown and unlikely efficacy, aducanumab has known serious side effects and high costs. Given the large downsides and unclear and unlikely benefits, I strongly support ICER’s report that states that there is insufficient evidence to support approval of aducanumab without further studies. [Read Article]
Clinical Efficacy, Drug Safety and Surrogate Endpoints: Has Aducanumab Met All of Its Expectations?
Linda A. Hershey, Rawan Tarawneh
...the patient and their caregivers need to understand that the clinical benefits of aducanumab are small and that more data will be needed in the future to determine whether these benefits are clinically or functionally meaningful to patients. [Read Article]
Aducanumab, Amyloid Lowering, and Slowing of Alzheimer Disease
Stephen Salloway, Jeffrey Cummings
Aducanumab opens a new era in AD research and care and provides a foundation for development of progressively better therapies. [Read Article]
Prescribing Aducanumab in the Face of Meager Efficacy and Real Risks
David S. Knopman, Joel S. Perlmutter
On the one hand, neurologists want to offer hope. Yet, aducanumab’s benefits are meager, if even present and there are non-trivial risks of side effects. [Read Article]
