An experimental Alzheimer’s drug, donanemab, was endorsed by a U.S. Food and Drug Administration (FDA) advisory panel on Monday.
Donanemab is designed to treat symptoms of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia.
At the FDA’s Peripheral and Central Nervous System Advisory Committee hearing, which was held in Maryland on Monday, the advisers unanimously agreed that the drug’s benefits outweigh any potential risks.
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While this isn’t a guarantee the FDA will approve the drug, the agency does typically follow the panel’s recommendations, per reports.
“The FDA held the advisory committee meeting to hear the viewpoints and assessments of the experts on both the benefits and the risks of donanemab,” the agency told Fox News Digital in an emailed statement.
“As with all applications the FDA receives, we will thoroughly review and consider the input from the committee.”
An experimental Alzheimer’s drug, donanemab, was endorsed by a U.S. Food and Drug Administration advisory panel on Monday. (iStock)
Officials at Eli Lilly, the Indiana pharmaceutical company that makes donanemab, were also in attendance, fielding questions from the committee about potential side effects.
At the Monday hearing, Eli Lilly officials presented clinical trial results that showed the drug slowed cognitive and functional decline for people with mild cognitive impairment due to early stages of Alzheimer’s.
The study was also published by the Journal of the American Medical Association.
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In phase 3 trials published in May 2023, donanemab was shown to “significantly slow cognitive and functional decline in people with early symptomatic Alzheimer’s disease,” according to a press release on Eli Lilly’s website.
If donanemab is approved, it would become only the second available medication designed to slow the progression of Alzheimer’s symptoms.
Donanemab is designed to treat symptoms of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia. (iStock)
Leqembi, the first new Alzheimer’s treatment in 20 years, was given full FDA approval in July 2023.
Donanemab works by clearing built-up amyloid from the brain. It was shown to cause side effects such as “brain swelling and tiny bleeds,” researchers found.
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The Alzheimer’s Association, based in Chicago, released a statement welcoming the FDA’s finding that donanemab is effective for the treatment of early Alzheimer’s disease.
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO, in a statement provided to Fox News Digital.
Eli Lilly officials presented clinical trial results showing that the drug, donanemab, slowed cognitive and functional decline for people with mild cognitive impairment due to early stages of Alzheimer’s. (iStock)
“Progress with treatment is happening. Now we need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety,” she continued.
“A rich and robust life without the threat of memory loss, confusion or cognitive decline — this is what we envision.”
The next step toward approval of donanemab is FDA review.
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center, noted that donanemab is very similar to Leqembi, the current drug on the market that blocks amyloid formation. (Dr. Marc Siegel)
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, who was not involved in the drug trials, noted that donanemab is very similar to Leqembi, the current drug on the market that blocks amyloid formation.
“A rich and robust life without the threat of memory loss, confusion or cognitive decline — this is what we envision.”
— Joanne Pike, CEO of the Alzheimer’s Association
“The problem with … denonemab is similar — it can cause brain swelling and bleeding,” Siegel told Fox News Digital.
“It is also expensive, as it’s once a month versus once every two weeks for Leqembi.”
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Denonemab is “somewhat more effective,” Siegel noted, as it slows progression of Alzheimer’s by about 35% versus 27% for Leqembi.
“It may be better at removing plaques,” he said.
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs,” the Alzheimer’s Association president and CEO said in a statement. (iStock)
There may be limitations associated with these types of drugs, however, according to the doctor.
“Many experts have told me that the obsession with amyloid formation may not be the holy grail it was once thought to be,” Siegel told Fox News Digital.
“The study didn’t pay enough attention to tau proteins, which are also a key player here.”
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Tau proteins, which cause “tangles” in the brain of Alzheimer’s patients, are not the primary targets of these drugs, Siegel said.
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“There is also the issue of neuroinflammation and neuronal transmission abnormalities, which precede the buildup of the plaque proteins and are important targets for research.”
In response, Eli Lilly provided the below statement.
“Lilly is pursuing multiple approaches to treat Alzheimer’s disease and other forms of dementia. Our pipeline of molecules in human testing includes ones aimed at amyloid (donanemab, remternetug), tau (OGA inhibitor), as well as lewy body dementia and frontotemporal dementia.”
Melissa Rudy is health editor and a member of the lifestyle team at Fox News Digital. Story tips can be sent to [email protected].
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