Strongest Alzheimer's phase 3 data release to date
Submitted by the Alzheimer’s Association
Today, Eli Lilly announced positive topline results from their phase 3 TRAILBLAZER-ALZ2 clinical trial of donanemab, an anti-amyloid monoclonal antibody for the treatment of early symptomatic Alzheimer’s disease.
The TRAILBLAZER-ALZ2 trial met all of its primary and secondary endpoints. Most encouragingly, the company reports that nearly half of the study participants taking donanemab had no decline of cognition and function for one year (47%, compared to 29% on placebo). Donanemab slowed clinical decline by 35% compared to placebo on the primary outcome measure, and resulted in 40% less decline in the ability to perform activities of daily living.
Alzheimer’s Association President and CEO Joanne Pike, Dr.P.H., said, "These donanemab phase 3 results are significant and further underscore the scientific evidence and personal benefit these types of treatments can have when people can get access to them. The Centers for Medicare & Medicaid Services policy to block Medicare access to Food and Drug Administration-approved Alzheimer's treatments is in stark contrast to scientific evidence, is unprecedented, and must be reversed immediately.”
Alzheimer’s Association Chief Science Officer Maria C. Carrillo, Ph.D., said, "These are the strongest phase 3 data for an Alzheimer's treatment to date. This further underscores the inflection point we are at for the Alzheimer's field. The progress we've seen in this class of treatments, as well as the diversification of potential new therapies over the past few years, provides hope to those impacted by this devastating disease. Yet, Medicare stubbornly continues to block access for the people who could benefit.
"We look forward to additional data from the TRAILBLAZER-ALZ2 trial at the Alzheimer's Association International Conference (AAIC) in July, including data on participant safety and representation. If those data are consistent with what we saw today regarding efficacy and safety, we strongly support FDA approval and, if approved, we expect CMS and other private insurance coverage.”
To learn more about Alzheimer’s disease or other dementias, call 800-272-3900 or visit alz.org.