It comes after the first-ever approval last year.
Alzheimer's disease affects millions of Americans as well as their families as they learn to live with their loved one navigating cognitive decline. Luckily, advancements have been made in the medical world that may help slow the rate of neurological breakdown, and the U.S. Food and Drug Administration just opened the door to more changes with its latest approval.
The FDA just approved Eli Lilly's new drug donanemab, sold as Kisunla, that the company showed in trials to be effective in combating the progression of Alzheimer's disease in affected people. It marks the second-ever Alzheimer's drug approval by the FDA after the agency gave the green light to Eisai and Biogen's drug lecanemab, sold with the name Leqembi, last year. It'll cost you, though; each vial of Kisunla is $695 before insurance.
Donanemab is a monoclonal antibody that works by helping the body remove amyloid plaque buildup in the brain, one of the most recognizable symptoms of Alzheimer's disease. Lilly told the FDA last month that its late-stage clinical research data showed "highly meaningful results," with patients who took it seeing an approximately 35 percent lower risk of progression of the disease over a year and a half compared to a placebo group.
"Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease, who urgently need effective treatment options," Lilly neuroscience president Anne White said in a statement. "We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis."
As with all drugs, Kisunla doesn't come without some risks. During the trial, scientists observed a two percent mortality rate among those who took the drug compared to 1.7 percent among placebo participants. They also noted that Kisunla "can cause amyloid-related imaging abnormalities (ARIA), which is a potential side effect with amyloid plaque-targeting therapies that does not usually cause symptoms."
ARIA can be detected via MRI scan and can be serious or even life-threatening if not taken seriously. Three people in the trial died while on a Kisunla treatment plan after developing ARIA. Lilly ended up adding an extra MRI exam to the trial after noticing most of the ARIA incidents popped up in the first six weeks of the trial, per CNN.
