The U.S. Food and Drug Administration (FDA) on Tuesday approved a new Alzheimer’s treatment called donanemab, which could slow progression of the mental disease that impacts millions of Americans, drugmaker Eli Lilly said.
The drug, which will be sold under the name Kisunla, is a type of monoclonal antibody infusion that is administered every four weeks and was shown in trials to slow the pace of decline in the early stages of Alzheimer’s. However, the drug presented several significant safety risks, including brain bleeding and swelling, according to a trial released last year.
Eli Lilly said the federal health regulator cleared the drug for usage in adults who have early Alzheimer’s disease or mild cognitive difficulties. The drug works by removing amyloid plaques in the brain, which has been associated with the disease.
Last year, the FDA blocked Eli Lilly’s request for a faster approval, adding that it had concerns about the drug’s safety data before the company then submitted more information.
In July 2023, a study published in the Journal of the American Medical Association suggested that Eli Lilly’s drug slowed decline by 35 percent compared with a placebo group. That study evaluated a measure of daily activities such as driving, engaging in hobbies, talking about current events, and managing finances.
Eli Lilly officials have said that people taking donanemab have a higher rate of injuries known as amyloid-related imaging abnormalities (ARIA) when compared with those who took a placebo. According to the study, three people died from “amyloid-related imaging abnormalities” during the study, and another two died after taking the drug following the conclusion of the study due to similar injuries.
The condition “is usually asymptomatic, although serious and life-threatening events can occur,” the company said in a news release issued last year. “In this study, the incidence of serious ARIA was 1.6 percent, including two participants whose death was attributed to ARIA and a third participant who died after an incident of serious ARIA. Infusion-related reactions occurred in 8.7 percent of participants with most cases mild to moderate in severity.”
Brain swelling and “microhemorrhages,” or bleeding—a known risk for this class of drugs—occurred in 24 percent and 31 percent respectively for those taking donanemab, the news release added.
In June, an FDA advisory panel unanimously recommended approval of the drug, saying that the benefits of donanemab outweighed its risks, and they agreed that trial data showed it was effective in patients with an early stage of the memory-robbing disease.
“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,” said Anne White, executive vice president and president of Lilly Neuroscience, in a news release issued on Tuesday.
The company official then extended “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.”
In response, the Alzheimer’s Association said the decision would allow Alzheimer’s sufferers to have “more options and greater opportunity to have more time,” adding that “multiple treatment options is the kind of advancement we’ve all been waiting for.”
Last year, the FDA approved the drug Leqembi but mandated that makers of the drug provide a warning about known side effects such as brain bleeding and swelling. Leqembi, made by Biogen, was the first drug that targeted amyloid proteins to gain FDA approval.
After the FDA’s approval on July 2, Eli Lilly said the medication will be available to the public in the coming weeks.
Reuters contributed to this report.
From The Epoch Times
