FDA Approves First Alzheimer's Drug in 18 Years
For the first time in nearly 20 years, the U.S. Food and Drug Administration has approved an Alzheimer’s drug giving much hope and excitement for patients and clinicians impacted by this devastating disease. Biogen’s aducanumab (Aduhelm) received FDA approval June 7, though it is conditional on conducting another trial under the accelerated approval pathway.
Both Banner Sun Health Research Institute and Banner Alzheimer’s Institute, Banner Health Centers of Excellence for the care and treatment for those with Alzheimer's disease and related dementias, were primary sites involved in one of the pivotal phase 3 studies. Our leaders, including Eric M. Reiman, MD; Pierre N. Tariot, MD; Jessica Langbaum, PhD; and Alireza Atri, MD, PhD; all served in a variety of consulting, advisory and independent safety board review roles for the drug. This approval is an important step forward in our fight to end Alzheimer’s before losing another generation. But it’s important to know that this is one step in a complex process ahead.
The aducanumab trials were prematurely discontinued, so the FDA’s approval has been met with mixed reactions in the field. Experts eagerly await results from ongoing trials of other amyloid-plaque reducing drugs in the next 1-3 years to know with greater certainty whether removal of amyloid plaques has a clinical benefit.
“The approved drug, and the completion of the other anti-amyloid drug trials in the next few years, will have a major impact on the field. We need to come together to identify and address the questions, challenges, and unprecedented opportunities at hand," said Banner Alzheimer's Institute Executive Director Dr. Reiman. "When we consider all of the relevant issues, "I am extremely excited about the chance to do so in ways that will transform the standard of memory care for patients and families and find effective prevention therapies within the next five years.”
Details of the Phase 4 plan are crucial to understanding what this means for clinical practice. Aduhelm will not be immediately available. It will take several months to appropriately address questions feeding into the decisions like cost, eligibility criteria, payer coverage and manufacturer supply that are impacting availability.
See the latest headlines with comments from our leaders to help understand the complexity of this decision here.
Untangling the FDA Approval of Aducanumab (Aduhelm)
Dr. Alireza Atri, Banner Sun Health Research Institute director and leader in clinical research for the past 20 years, joins the conversation to help untangle the renewed hope in the field and the complexities surrounding this decision. Dr. Atri acknowledges that this is an important step forward in our fight to end Alzheimer’s before losing another generation, but it’s one step in a complex process ahead. Tune in to hear him discuss what steps care partners and those with the disease should take with their physician, and just how soon this treatment may be available to qualified candidates.
June 11, 2021