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.
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. 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 ben.