An experimental Alzheimer’s drug slowed the decline in patients’ ability to think clearly and perform daily tasks by more than a third in a large clinical trial, pharmacist Eli Lilly said Wednesday. From the report. Based on the results in people with early-onset Alzheimer’s disease, Lilly said he plans to apply to the U.S. Food and Drug Administration for approval by the end of June. The drug donanemab works by removing plaque deposits in the brain, known as amyloid, that are a hallmark of Alzheimer’s disease. However, there were some side effects. There were three deaths in the trial among people taking the drug, two of which were attributed to adverse events such as brain swelling or microbleeds known as amyloid-related imaging abnormalities, or ARIA. The trial was conducted in more than 1,700 patients for 18 months.
“For every drug, for every disease, there are potential risks and potential benefits,” said Lilly’s Chief Scientific and Medical Officer, Dr. Daniel Skowronsky. But he noted that almost half of the participants taking the drug, 47%, had no decline in a key measure of cognition over a year, compared with 29% of people taking a placebo. That’s “an efficacy that’s never been seen before in Alzheimer’s disease,” Skowronski said. According to Lilly, more than 6 million Americans are affected by Alzheimer’s disease, with an estimated 1.7 million to 2 million people over the age of 65 in the early stages of the disease. Alzheimer’s drug development is fraught with setbacks, but Lilly’s drug is among a promising new group. The first, Eisai and Biogen’s Leqembi, received accelerated FDA approval in January.