Information Document, Shiley-Marcos ADRC
As you might expect, with the news of the approval of Aduhelm (aducanumab) for Alzheimer's disease, our center has received several inquiries seeking more information. This document is not intended to provide all the answers, but we are posting it to provide a brief background of what is known thus far. We hope you find it helpful and we will remain in communication with our participants and partners as we learn more.
On June 7, 2021, the US Food and Drug Administration (FDA) granted conditional approval to aducanumab, a medication designed to remove amyloid, a protein that accumulates in the brains of patients with Alzheimer's disease.
The medication is delivered monthly by infusion, which means it is given through the blood by trained personnel in a specialized setting. It also means that the processes for its delivery are not simple and will take some time for medical centers and insurance payers to set up the infrastructure and processes for delivery and possible reimbursement (payment).
The approval was granted under the FDA's accelerated approval pathway, intended for drugs that target serious diseases and that are expected to provide an advantage over existing therapies, but where there is residual uncertainty regarding the drug's ultimate clinical benefit.
The drug's ultimate clinical benefit is very much in question, which explains the newsworthiness of the controversy over the drug's approval, its cost, and the highly charged and differing views on whether the FDA's decision was appropriate.
We stand ready to support our participants and patients in approaching the topic from a well-informed viewpoint, which, along with their primary physician input, will help decide whether pursuing this medication will be right for their personal situation.
We hosted an "Ask the Experts" Q&A Live Zoom on 6/22/21. A recording of the live event can be found here.
A few links to additional information follows:
1. Memorandum from Billy Dunn, Director of the Office of Neuroscience at the FDA, to review panel members regarding the conditional approval of aducanumab.
2. Neurology today article highlighting neurology specialist viewpoints regarding the approval of aducanumab
3. Link to additional summary/Q&A by our close colleague, Josh Grill from UC Irvine.