Alzheimer's Association Statement on Donanemab Phase 3 Topline Data Release

• Strongest Alzheimer's Phase 3 data release to date
• Association underscores urgent call for CMS to stop blocking access to FDA-approved treatments
• Full readout expected at Alzheimer's Association International Conference in July

CHICAGO, May 3, 2023 /PRNewswire/ -- On behalf of the millions of Americans impacted by the devastation of Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes the robustly positive topline data reported today by Eli Lilly on the TRAILBLAZER-ALZ2 Phase 3 clinical trial of donanemab for the treatment of early symptomatic Alzheimer's disease.

"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 (CMS) policy to block Medicare access to Food and Drug Administration (FDA)-approved Alzheimer's treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately," said Joanne Pike, DrPH, Alzheimer's Association president and CEO.

The TRAILBLAZER-ALZ2 trial met all of its primary and secondary endpoints. Most encouragingly, the company reports that nearly half (47%) of the study participants taking donanemab had no decline of cognition and function for one year (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.

"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," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer. "Yet, Medicare stubbornly continues to block access for the people who could benefit."

For people in the earliest stages of Alzheimer's, these results suggest donanemab will significantly change the course of the disease. Like the other treatments in its class already approved by the FDA, Aduhelm™ and Leqembi™, these results indicate donanemab gives people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions. Treatments that deliver these benefits are just as valuable as treatments that extend the lives of those with other diseases.

Since April 2022, CMS has denied access to FDA-approved Alzheimer's treatments through a National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease. This NCD would also apply to donanemab if it is approved for use by the FDA. CMS has repeatedly pledged to move quickly to modify the NCD if warranted by new evidence — yet they have failed to do so to date. Today's topline data is further evidence that this class of treatments can provide a meaningful benefit to people living with early Alzheimer's. We urge CMS to immediately review existing data just as the U.S. Veterans Health Administration did.

Medicare beneficiaries living with Alzheimer's, a fatal disease, deserve the same immediate, full coverage under Medicare afforded to those with other diseases.

According to the company, "The [overall] incidence of amyloid-related imaging abnormalities (ARIA) was consistent with the TRAILBLAZER-ALZ Phase 2 study." They shared that the incidence of serious ARIA was 1.6%, including two participants whose deaths were attributed to ARIA and a third participant who died after an incident of serious ARIA. As with other anti-amyloid treatments — in fact, every drug — this treatment has side effects. Patients living with a fatal disease should have the opportunity to talk with their doctors to develop a treatment plan that is right for them, including weighing the benefits and risks of approved therapies.

"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," said Carrillo.

The results of this and other positive trials clearly demonstrate the importance of an early and accurate diagnosis on treatment and health outcomes. In this trial, participants had confirmation of both amyloid and tau by PET scans. Advancements in diagnostic tools that detect these disease-specific brain changes allowed for precision in patient selection and more thorough understanding of the impact of the treatment for participants.

As we reflect on the importance of the positive results announced today, the Alzheimer's Association remains committed to advancing all potential treatment avenues and exploring methods for combining diverse approaches into combination therapies. There must be access to any approved treatments, as well as quality care and support for all people.

Alzheimer's Association
The Alzheimer's Association leads the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia. Visit alz.org or call the 24/7 Helpline at 800.272.3900.

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SOURCE Alzheimer's Association