Voices of Alzheimer's Applauds Approval of Kisunla for Early Disease Treatment

Voices of Alzheimer's, a national advocacy organization led by people living with Alzheimer's disease, today announced it celebrates the U.S. Food and Drug Administration's (FDA) decision to grant traditional approval of donanemab (Kisunla) for treating 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.

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.

Jim Taylor, President & CEO of Voices of Alzheimer's and husband to Geri, who was diagnosed with Alzheimer's in 2012, said in a press release on July 2, 2024, "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 supporting 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."

In light of this news, Voices of Alzheimer's reiterates our call for the Centers for Medicare and Medicaid Services to remove coverage with evidence development requirements for the entire class of monoclonal antibody treatments for Alzheimer's.

The total cost of Kisunla will vary by patient based on when they complete treatment, says Eli Lilly.

Lilly Support Services for Kisunla is a free support program committed to helping patients navigate treatment with Kisunla. The program includes coverage determination assistance, care coordination, nurse navigator support, customized support, and resources. For more information, visit www.Kisunla.Lilly.com or call 1-800-LillyRx (1-800-545-5979).

Alzheimer's disease preventive vaccine candidates continue to be researched in clinical trials.