TUESDAY, June 11, 2024 (HealthDay News) — A U.S. Food and Drug Administration advisory panel voted unanimously Monday to recommend that the benefits of a new Alzheimer’s drug outweigh its harms , which can include inflammation and bleeding in the brain.
Eli Lilly’s donanemab slowed the decline in thinking skills in early-stage Alzheimer’s patients: The company’s data showed that patients taking donanemab had a 37% lower risk of disease progression over 18 months compared with patients who received a placebo.
The drug was expected to be approved earlier this year, but the FDA decided in March that it would instead subject donanemab to the scrutiny of an independent advisory panel.
Since Alzheimer’s disease affects more than 6 million Americans and there is no cure or lifestyle change that can resurrect memory loss, Monday’s panel concluded that the consequences of Alzheimer’s disease are as significant that even a modest benefit can be worth it.
“There is a huge unmet need here,” said Sarah Dolan, a consumer representative on the panel, the New York Times reported.
Donanemab works by targeting amyloid, a protein that can build up in patients’ brains.
Two similar drugs were recently approved to combat amyloid. Leqembi, made by Eisai and Biogen, was approved last year with modest risks and benefits similar to donanemab. Meanwhile, Aduhelm, also made by Biogen, was approved in 2021 but was discontinued because there was insufficient evidence that it helped patients.
Reaction to Monday’s panel vote was mixed.
“A future with more approved treatments for Alzheimer’s is a huge step forward for people eligible for these medications. Progress with treatment is happening,” Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.
“We now need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety. This will lead to possibilities for combination therapies that address the complexity of the disease,” Pike added.
But others were less enthusiastic.
“The advisory committee meeting was very disappointing. The essential issue was not the details of the potential prescribing information for donanemab, but whether the drug should be approved in the first place,” Dr. Robert Steinbrook, director of the Donanemab Group, said in a statement. Public Citizen Health Research. “The FDA should never have approved the Alzheimer’s drug aducanumab [Aduhelm] and lecanemab [Leqembi]. “You should not make the same mistake a third time by approving donanemab.”
“All three drugs have the same problem: Their purported benefits in slowing the progression of Alzheimer’s disease do not outweigh their substantial health risks, including inflammation and bleeding in the brain,” the nonprofit consumer advocacy group’s statement concluded. profit. Although Alzheimer’s disease patients and their families are desperate for effective treatments, donanemab is not the answer, and should not be approved.”
In the trial data that Lilly submitted to the FDA, declines in thinking were slowed by 4 1/2 to 7 1/2 months in those taking donanemab compared to those receiving placebo.
On the other hand, three patients taking donanemab died from brain inflammation or bleeding that was linked to the drug.
Also discussed during the panel meeting was the fact that study participants stopped taking the drug as soon as their amyloid disappeared, the Times reported.
Lilly’s decision to stop treating patients as soon as a brain scan indicated their amyloid had disappeared appealed to some panel members because patients could avoid ongoing monthly infusions, the risks of treatment and higher care costs. health higher, the Times reported.
Still, the committee had doubts about stopping the treatments.
Dr. Constantino Iadecola of Weill Cornell Medicine in New York City noted that it was unclear how patients would be monitored after they stopped taking the drug.
“Monitoring is going to be necessary,” he told the Times. And “how soon will you need to intervene if you have a sign of increased amyloid?” he added.
Lilly scientists have estimated that it would take almost four years for amyloid levels to rise above the threshold again.
More information
Visit the Alzheimer’s Association to learn more about medications for Alzheimer’s disease.
SOURCE: New York Times
