• Posted June 11, 2024

FDA Advisors Support New Alzheimer's Drug

A U.S. Food and Drug Administration advisory panel voted unanimously on Monday to recommend that the benefits of a new drug for Alzheimer's outweigh its harms, which can include brain swelling and bleeding.

Eli Lilly's donanemab did slow declines in thinking skills in patients with early-stage Alzheimer's: Company data showed patients who took donanemab had a 37% lower risk of progression of the disease over 18 months compared to patients who got a placebo.

The medication was first 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.

Given that Alzheimer's strikes over 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 are so significant that even a modest benefit can be worthwhile.

"There is a huge unmet need here,"said Sarah Dolan, the panel's consumer representative, the New York Times reported.

Donanemab works by targeting amyloid, a protein that can pile up in patients' brains.

Two similar amyloid-fighting drugs were approved recently. Leqembi, made by Eisai and Biogen, was approved last year with risks and modest benefits similar to those of donanemab. Meanwhile, Aduhelm, also made by Biogen, was approved in 2021 but was discontinued because there was insufficient evidence it helped patients.

Reaction to Monday's panel vote was mixed.

"A future with more approved Alzheimer's treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,"Joanne Pike, president and CEO of the Alzheimer's Association, said in a statement.

"Now we 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 specifics of the potential prescribing information for donanemab but whether the drug should be approved to begin with," Dr. Robert Steinbrook, director of Public Citizen's Health Research Group, said in a statement. "The FDA should never have approved the Alzheimer's disease drugs aducanumab [Aduhelm] and lecanemab [Leqembi]. It 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 brain swelling and bleeding," the statement from the nonprofit consumer advocacy group concluded. "Although patients with Alzheimer's disease 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, thinking declines were slowed by about 4½ to 7½ months in those taking donanemab compared with those who got the placebo.

On the other hand, three patients taking donanemab died from brain swelling or bleeding that was linked to the drug.

Also at issue during the panel meeting was the fact that study participants stopped taking the drug as soon as their amyloid cleared, the Times reported.

Lilly's decision to stop treating patients as soon as a brain scan indicated their amyloid had cleared appealed to some panel members because patients could avoid continuous monthly infusions, treatment risks and higher health care costs, the Times reported.

Still, the committee had questions about halting treatments.

Dr. Constantino Iadecola, of Weill Cornell Medicine in New York City, noted it wasn't clear how patients would be monitored after they stop taking the drug.

"Monitoring is going to be necessary,"he told the Times. And "how soon will you have to intervene if you have a signal of amyloid going up?"he added.

Lilly scientists have estimated it would take nearly four years for amyloid levels to bump up over the threshold again.

More information

Visit the Alzheimer's Association for more on Alzheimer's drugs.

SOURCE: New York Times