OAN’s Brooke Mallory
Tuesday, July 2, 2024 3:50 PM
Donanemab is a monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) on Tuesday to slow the progression of early-stage Alzheimer’s disease.
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Indianapolis-based Eli Lilly makes a drug called donanemab that may help remove the buildup of amyloid plaque in the brain, a key sign of Alzheimer’s disease.
Lilly said the drug, to be sold under the name Kisunla, will cost $695 per vial before insurance coverage, ranging from $12,522 for a six-month course of treatment to more than $32,000 for a year, depending on when a patient completes the treatment.
Clinical trials have demonstrated that donanemab can slow the progression of Alzheimer’s disease, helping people live longer and safely functioning in their daily lives. However, the drug does not cure Alzheimer’s disease.
Lilly told an FDA advisory group in June that late-stage clinical trial data showed “highly meaningful results” for donanemab users, who reduced their risk of disease progression by about 35% over a year and a half compared with placebo users. The FDA advisory committee agreed that the treatment is sufficiently safe that it poses no threat to the vast majority of consumers.
But Lilly also told the committee that while serious side effects were rare, they did occur during the drug’s trials, affecting 2 percent of participants. The small number of patients who received donanemab “had a slightly higher mortality rate — 2 percent compared with 1.7 percent in the placebo group,” Lilly said. CNN.
Three patients who experienced ARIA (amyloid-related imaging abnormalities) died while taking the drug. Lilly told FDA advisers that because the majority of ARIA episodes occurred in the first six weeks of the study, the company built additional MRI scans into the study before the second dose to identify participants with asymptomatic ARIA. If ARIA is identified, medical professionals will stop treatment to allow it to resolve on its own and to prevent the condition from worsening or new symptoms from appearing.
Although less common than in the donanemab study, ARIA was also experienced by some patients in clinical trials of another drug, Rekembi, which has also been linked to patient deaths.
Lilly said Tuesday it was “collaborating with others” to enhance early detection and diagnosis, as the drug is most effective when used early in the disease’s symptoms.
“Every year, more people are at risk for this disease, and we are determined to make their lives better,” said Anne White, executive vice president and president of Lilly Neuroscience.
According to the Alzheimer’s Association, one in three older Americans will die from Alzheimer’s disease or another type of dementia, killing more people than breast and prostate cancer combined.
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