FDA Approves Eli Lilly Alzheimer’s Drug

The United States Food and Drug Administration (FDA) has officially approved a drug by the manufacturer Eli Lilly called Kisunla to treat Alzheimer’s disease. The medication will help patients with early symptoms of the disease.

The Eli Lilly website reports that the drug will treat adults with “mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.”

Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company, stated in the press release, “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. 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.”

FDA has approved a treatment for Alzheimer’s disease. This treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in the clinical trials: https://t.co/Y5smTGfWvR pic.twitter.com/iovxGJ7H62

— FDA Drug Information (@FDA_Drug_Info) July 2, 2024

White continued, “Our deepest thanks to the patients and their loved ones for participating in our clinical programs and to Lilly scientists and collaborators persevering over decades of research. Each year, more and more people are at risk for this disease, and we are determined to make life better for them.”

Kisunla will help the body remove the buildup of amyloid plaques, which are proteins that clump together and cause memory issues associated with Alzheimer’s disease. The drug can reportedly slow the cognitive decline that comes with the disease.

Nearly 7 million Americans have the condition, the fifth-leading cause of death for adults over 65 in 2021, according to the Alzheimer’s Association. By 2050, that group will rise to almost 13 million in the U.S.

The FDA rejected the drug’s approval last year due to insufficient data. It was delayed again in March, per CNBC. In June, an advisory panel to the agency recommended the treatment for full approval, saying the drug’s benefits outweigh its risks. 

CNN reports that Kisunla will cost $695 per vial before insurance. That amounts to $12,522 for a six-month course or about $32,000 for a year. This price reflects the total amount of cost for a patient to complete a course of treatment depending on the severity of their condition.