Media requests should be directed to: 

Katy Riddick, Voices of Alzheimer’s Secretariat  

E-mail: kriddick@highlanterngroup.com 

Phone: +1 202 223 2027 

FOR IMMEDIATE RELEASE 

OUR MINDS. OUR LIVES. OUR CHOICES. 
VoA Celebrates Groundbreaking Donanemab Clinical Trial Results  

Washington, DC, July 17, 2023 – Voices of Alzheimer's celebrates the groundbreaking donanemab Phase 3 clinical trial data released in full today at the Alzheimer's Association International Conference (AAIC) in Amsterdam, demonstrating that the treatment significantly slowed cognitive and functional decline in early Alzheimer's disease.  

Drugmaker Eli Lilly released the full results of its TRAILBLAZER-ALZ 2 Phase 3 study for the new Alzheimer's treatment donanemab today at AAIC. The data released expands on the previous announcement by Eli Lilly of positive results in slowing Alzheimer's and marks another significant step forward in the development of disease-modifying treatments. 

Jim Taylor, President of Voices of Alzheimer's and a long-time care partner, said, "These results are a cause for celebration. For decades, people living with Alzheimer's had nowhere to turn, with no real options for treatment. Now, in just the last month, our community saw the first-ever FDA traditional approval of a disease-modifying treatment for early Alzheimer's, and today celebrate these promising results for donanemab. After years of struggle, we have finally turned a corner in the fight against Alzheimer's disease." 

Taylor added, "We urge the FDA to promptly consider the newest data and speedy approval of donanemab. The millions of people living with Alzheimer's who these treatments can help need and deserve options for their care."  

The results released by Eli Lilly showed that its new treatment, donanemab, has several important findings for patients. Donanemab significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer’s disease patients, lowering their risk of disease progression; nearly half of participants at an earlier stage of disease on donanemab had no clinical progression at one year.  Furthermore, the treatment effect continued to increase relative to placebo over the course of the trial, even though many participants completed their course of therapy at 6 or 12 months, supporting limited duration dosing. 

While we celebrate these results, this is yet another example showing why the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination for the entire class of monoclonal antibody treatments for Alzheimer's is a mistake. The donanemab data are further compelling evidence demonstrating the safety and efficacy of these treatments, yet CMS continues not to integrate that evidence into their decision-making. It is not too late for CMS to reverse its flawed policy that could delay or deny access to donanemab and other treatments for people with early Alzheimer's. 

Voices of Alzheimer's looks forward to the consideration of donanemab for FDA approval and to coverage of the treatment for any Medicare beneficiary medically eligible. We will continue to advocate on behalf of people living with Alzheimer's to ensure they have access to the diagnostic tools and treatments they need and deserve. 

About Voices of Alzheimer's 

Voices of Alzheimer's is a non-profit organization dedicated to advocating for the rights and well-being of people living with Alzheimer's disease. Our mission is to empower people living with or at risk of Alzheimer’s and other cognitive illnesses, united by urgency, to drive equitable access to innovation in treatment and care. We are guided and led by those affected by Alzheimer’s, but with a broad membership including those individuals in the generation at risk.  Our primary focus is to draw attention to the unmet medical needs of people with Alzheimer’s – especially to ensuring the FDA and CMS get meritorious products approved and into the hands of patients. 

Learn more on the Voices of Alzheimer’s website, and on social media through Facebook, Twitter, Instagram, and TikTok. 
 

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@VoicesOfAlz