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. 
Voices of Alzheimer's Applauds the FDA's Approval of Donanemab for Early Alzheimer's  

Washington, DC, July 2, 2024 – Voices of Alzheimer's, a national advocacy organization led by people living with Alzheimer's disease, celebrates the U.S. Food and Drug Administration's (FDA) decision to grant traditional approval of donanemab, brand name Kisunla, for the treatment of early Alzheimer's disease. Following last year's first-ever traditional approval of a drug to slow the progression of Alzheimer's, today's decision builds on that progress by providing patients, care partners, and providers with another alternative to care during the early stages of the disease.

Jim Taylor, President & CEO of Voices of Alzheimer's and husband to Geri, who was diagnosed with Alzheimer's in 2012, said, "Today is a day for celebration in the Alzheimer's community. When doctors diagnosed my wife Geri with Alzheimer's, there was not a single approved treatment to slow the progression of the disease. Now, a decade later, we have two traditionally approved disease-modifying treatments and further advancements in the pipeline."

Taylor continued, "I am also encouraged by the evidence in support of stopping treatment with Kisunla when amyloid plaques are removed. People living with Alzheimer's and their care partners already face significant costs and burdens in their day-to-day lives. The possibility of stopping treatment could translate to lower costs and a reduced treatment burden."

While Kisunla is not a cure, new treatment options still bring tremendous hope to affected families and offer priceless additional time for people in the early stages of Alzheimer's disease. With today’s approval, eligible individuals now have two FDA-approved treatment options that can extend their independence and improve their quality of life. Our fight against Alzheimer's disease is far from over, but millions of Americans today can rest a little easier knowing they have another option at their disposal.

Doreen Monks, a Voices of Alzheimer's Board Member living with Alzheimer's disease, said, "This hard-fought victory is a monumental step forward for the Alzheimer's community. People in the early stages of Alzheimer's are facing years of an illness that will progressively rob us of our independence and ability to function. Like anyone would, we want a choice regarding our treatment. The FDA's approval of Kisunla gives us another option that can allow us to live life on our own terms for as long as possible."

In light of this news, Voices of Alzheimer's reiterates our call for the Centers for Medicare and Medicaid Services (CMS) to remove coverage with evidence development requirements for the entire class of monoclonal antibody treatments for Alzheimer's. While not so restrictive as to make treatment entirely inaccessible, the CED requirements still create an unnecessary burden to providers and patients seeking care. Both public and private payers need to cover disease-modifying therapies and remove any barriers to access for people eligible for treatment.

About Voices of Alzheimer's 

About Voices of Alzheimer's: Voices of Alzheimer's (VoA) is a 501 (c)(4) non-profit organization dedicated to advocating for the rights and well-being of people living with Alzheimer's disease. VoA is guided and led by those affected by Alzheimer's and maintains a broad membership of people from across the United States.

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

VoicesOfAD.com 

@VoicesOfAlz