FDA approves donanemab, Eli Lilly’s treatment for early Alzheimer’s disease

(CNN) — The US Food and Drug Administration on Tuesday approved donanemab, a monoclonal antibody designed to slow the progression of early symptomatic Alzheimer’s disease.

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 told a committee of FDA advisers in June that late-stage clinical research data showed “highly meaningful results” for people who took donanemab, with about 35% lower risk of progression of the disease over a year and a half compared with those who got a placebo. The FDA advisers voted that the treatment appeared safe and effective.

Although rare, there were some serious adverse events during the drug trial, Lilly told the committee, occurring in only 2% of patients. The participants who took donanemab had a slightly higher mortality rate: 2%, compared with 1.7% in the placebo arm of the trial.

Three people died while taking the drug after developing ARIA, micro-hemorrhages known as amyloid-related imaging abnormalities. Because most of the ARIA incidents came in the first six weeks of the trial, Lilly told the FDA advisers that it added another MRI exam to the trial before giving second doses in order to detect people with asymptomatic ARIA. If it was detected, providers would pause treatment so it could resolve and not become more serious or symptomatic.

Kisunla is not the first monoclonal antibody treatment approved to treat early Alzheimer’s. Eisai and Biogen’s lecanemab, sold as Leqembi, is already being used. Another drug by Biogen, aducanumab, sold as Aduhelm, in 2021 became the first such therapy to get accelerated FDA approval, but the company said it will stop making it by the end of this year as it shifts resources to its other Alzheimer’s drug.

In trials of Leqembi, the drug that’s already on the market, some participants also had ARIA, but it was at a lower rate than seen in the donanemab trial. Leqembi has also been tied to patient deaths.

Kisunla was approved with instructions that prescribers can consider stopping the patient’s treatment if they see improvement based on brain scans. The potential to complete the treatment after a limited course of therapy, Lilly said, could lower out-of-pocket costs. Kisunla otherwise costs more than Leqembi, which runs about $26,500 per year.

Lilly said Tuesday 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.

One in three older Americans dies with Alzheimer’s disease or another form of dementia, according to the Alzheimer’s Association, killing more people than prostate and breast cancer combined.

Successful treatments for Alzheimer’s can’t come fast enough, advocates for patients say, and could be a big help to a growing number of people who are predicted to develop the disease. The number of people projected to have Alzheimer’s is predicted to grow to nearly 14 million by 2060, according to the US Centers for Disease Control and Prevention. As of 2023, about 6.7 million Americans 65 and older live with Alzheimer’s.

The disease doesn’t just affect patients. More than 11 million family members and unpaid caregivers provided an estimated 18 billion hours of care to people with Alzheimer’s and other dementias in 2022 alone, research shows, while there has been an ongoing shortage of paid workers and medical professionals.

The Alzheimer’s Association said Tuesday that it was celebrating the announcement of the approval of the treatment.

“This is real progress. Today’s approval allows people more options and greater opportunity to have more time,” Dr. Joanne Pike, the group’s president and CEO, said in a news release. “Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.”