The FDA has approved donanemab, Eli Lilly's therapy for early Alzheimer's disease

Donanemab, a novel treatment for Alzheimer's disease, received FDA approval on Tuesday, paving the way for the third medicine to be added to a new class that aims to halt the disease's progression in people who are still in the early stages of the illness.

Eli Lilly, based in Indianapolis, manufactures a medication called donanemab that helps the body get rid of amyloid plaque accumulation in the brain, which is a sign of Alzheimer's disease.

According to Lilly, it will be marketed under the name Kisunla and will cost $695 each vial before insurance. Depending on when the patient finishes their therapy, this works out to $12,522 for a six-month course of treatment or over $32,000 for a year.

According to the company, the FDA approved the medication for use in persons with early-stage Alzheimer's disease or moderate cognitive impairment.

According to Eli Lilly, the medication will be accessible a few weeks after approval.

"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," Anne White, president of Eli Lilly's neuroscience arm, said in a news release.

Every four weeks, patients in Eli Lilly's trials received intravenous donanemab infusions for about 30 minutes. Patients were able to discontinue the medication as early as six months, based on brain scans that measured the amount of amyloid in their brains.

The business reports that after using the medication for almost a year, nearly half of the patients were able to significantly reduce their levels of amyloid. One year after therapy concluded, there was no "rebound of amyloid plaque" observed by the patients.

Clinical trials have demonstrated that donanemab slows the progression of Alzheimer's disease, allowing patients to live longer and safely engage in daily activities. However, it is not a cure for the disease.

Similar to other medications in its class, Kisunla can have potentially fatal side effects, such as brain hemorrhage and edema. The FDA reports that three deaths were connected to the medicine, despite the fact that the majority of instances found in the trial were minor.

After Leqmebi, Kisunla is currently the second approved medication for Alzheimer's disease of its sort. Aduhelm, a medication manufactured by Biogen, was removed from the market earlier this year.

The Alzheimer's Association estimates that 6.7 million Americans 65 years of age and older have Alzheimer's in 2023. By 2060, the number is expected to rise to 13.8 million.