7/3/24 - FDA Approves New Alzheimer's Drug

The FDA approved a new drug for treating Alzheimer’s disease. Donanemab, or Kisunla, is the third drug approved drug to target the buildup of amyloid protein in the brain.

(FDA Press Release) -  The U.S. Food and Drug Administration approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease.

“Alzheimer's disease is a devastating disease for the person diagnosed and their loved ones,” said Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “The trial data demonstrated, convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease. Today’s approval is evidence of the FDA’s commitment to helping more safe and effective drugs to treat Alzheimer’s disease become available.” 

Donanemab, made by Indianapolis-based Eli Lilly, works by helping the body remove amyloid plaque buildup in the brain, a hallmark of Alzheimer’s disease.

Lilly said it will be sold under the name Kisunla and would cost $695 per vial before insurance, what would amount to $12,522 for a six-month course or about $32,000 for a year, depending on when the patient would complete their treatment.

Donanemab is not a cure, but clinical trials showed that it slowed the progression of Alzheimer’s, allowing people to live independent lives for longer and safely participate in everyday activities.

Lilly said that because the medicines work best in the early symptomatic stage of the disease, it’s working with others to improve early detection and diagnosis.

“Each year, more and more people are at risk for this disease, and we are determined to make life better for them,” said Anne White, executive vice president and president of Lilly Neuroscience.

 As of 2023,  about 6.7 million Americans 65 and older live with Alzheimer’s.