CNN
—
An experimental Alzheimer’s drug reduced the decline in patients’ ability to think clearly and perform daily tasks by more than a third in a large clinical trial, drugmaker Eli Lilly said Wednesday.
Based on the results, in people with early symptomatic Alzheimer’s disease, Lilly said it plans to apply for US Food and Drug Administration approval by the end of June.
The drug, donanemab, works by removing the buildup of plaque in the brain known as amyloid, which is a hallmark of Alzheimer’s disease. However, some side effects were reported; 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 carried out on more than 1,700 patients over 18 months.
“For every drug, for every disease, there are potential risks and benefits,” said Lilly’s chief medical and scientific officer, Dr. Daniel Skovronsky. But he noted that almost half of the participants taking the drug, 47%, did not show a decline in a key measure of cognition over the course of a year, compared with 29% of people taking a placebo. .
That’s “the kind of efficacy that has never been seen before in Alzheimer’s disease,” Skovronsky said.
Alzheimer’s affects more than 6 million Americans, with an estimated 1.7 million to 2 million people age 65 and older in the early stages of the disease, according to Lilly. Alzheimer’s drug development has been plagued with failures, but Lilly’s drug is among a new group showing promise. The first, Eisai and Biogen’s Leqembi, received accelerated approval from the FDA in January.
Skovronsky, who noted that he has been working in the Alzheimer’s field for 25 years, said the new class of drugs is different because of “how much amyloid they can remove and how quickly they can remove it.”
The medicine is given by infusion once a month. Donanemab removes amyloid so effectively, the company says, that the majority of patients in the trial, 52%, were able to stop taking the drug at one year and 72% at one and a half years. The researchers will continue to monitor the progress of these patients.
In the trial, the researchers looked at the participants in two groups, separated by levels of a brain protein known as tau. A 35% decrease in cognitive and functional decline was seen in the intermediate tau group, whose disease had not progressed as far. When this middle group was combined with the group with the highest tau levels, the figure was 22%. The results have not been peer reviewed or published in a journal.
lily filed a request for expedited approval with the FDA for donanemab based on previous results, but was rejected in January when the agency sought more data. With these results, the company will seek full approval, which is expected to lead to broader insurance reimbursement for the drug. Leqembi received accelerated approval in January, and the drug is not expected to be widely covered by Medicare until it also receives full approval, most likely in early July.
Leqembi is priced at $26,500 a year. Skovronsky declined to discuss the potential price of donanemab before the drug is approved.
—————————————————-
Source link