There isn’t a cure for Alzheimer’s disease, the most common form of dementia in the U.S., but a third treatment for the condition is on its way to be approved by the U.S. Food and Drug Administration.
Nature reported that a group of 11 independent scientists advising the FDA gave a unanimous recommendation for the approval of donanemad during a Monday meeting in Silver Spring, Md. This antibody treatment targets amyloid plaques, proteins that build up in the brain and are a marker for Alzheimer’s. Twisted fibers of protein called tau are another marker.
Nearly 7 million people in the U.S. have Alzheimer’s disease, which causes loss of memories and cognitive abilities that interfere with daily life.
According to the Chicago, Ill.-based Alzheimer’s Association, “donanemab will be the second traditional approval of an Alzheimer’s treatment that changes the underlying course of the disease, and the third FDA approval overall in this class of treatments.”
In May 2023, Indianapolis, Ind.-based Eli Lilly and Company announced that results of a Phase 3 study showed that donanemab “significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease,” and that it met the primary endpoint on the integrated Alzheimer’s Disease Rating Scale.
Nature noted that “donanemab’s effects are modest,” and that “it does not reverse symptoms” though it has been effective at treating people in early stages of the disease. While the advisory committee gave unanimous approval, the journal said that some were surprised that the committee was convened at all – they expected the treatment to be quickly approved by the FDA.
“Instead the FDA delayed its decision until after a public meeting could be held because of questions about the drug’s efficacy in people with certain markers of Alzheimer’s disease,” said Nature.
Still, neurologist David Knopman of the Mayo Clinic in Rochester, Minnesota, who was not on the committee, said the meeting was very positive.
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,” said Joanne Pike, Alzheimer’s Association president and CEO.
As more treatments are approved, there are more opportunities to combine therapies and address the complexities of the disease, she explained. In addition to donanemab, aducanumab and lecanemab are FDA approved Alzheimer’s treatments. Aducanumab’s production has been discontinued by its maker, Biogen. All three treatments target amyloids.
According to the Alzheimer’s Association, the next step for donanemab is FDA review. Apart from medications researchers recently identified how mitochondria might play into proteins collecting in the brain.