an experimental alzheimer’s drugOn Monday, a US Food and Drug Administration (FDA) advisory panel backed the drug, called donanemab.
Donanemab is designed to treat symptoms in the early stages. Alzheimer’s diseaseThat includes mild cognitive impairment and mild Alzheimer’s dementia.
At a hearing of the FDA’s Peripheral and Central Nervous System Advisory Committee, held in Maryland on Monday, advisers unanimously agreed that the drug’s benefits outweigh any potential risks.
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While it’s not a guarantee that the FDA will approve the drug, the agency typically follows the panel’s recommendations, according to reports.
Also in attendance were officials from Eli Lilly, the Indiana-based pharmaceutical company that makes donanemab, who answered the committee’s questions about potential side effects.
On Monday, an advisory panel to the US Food and Drug Administration approved the experimental Alzheimer’s drug donanemab. (iStock)
Eli Lilly executives presented at Monday’s hearing Results of diagnostic tests This showed that the drug slowed cognitive and functional decline for people with mild cognitive impairment due to the early stages of Alzheimer’s.
This 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 will become the second available drug 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)
Lekembi, the first new alzheimer’s treatment For the first time in 20 years, a drug has been introduced to market, and it will be granted full FDA approval in July 2023.
Donanemab works by clearing amyloid deposits in the brain. Researchers found that it causes side effects such as “swelling and small bleeding in the brain.”
The Chicago-based Alzheimer’s Association issued a statement welcoming the FDA’s conclusion that donanemab is effective for treating early-onset Alzheimer’s disease.
“A future with more approved treatments for Alzheimer’s is a tremendous advancement for those eligible for these medications,” said Dr. Joan Pike, president and CEO of the Alzheimer’s Association, in a statement provided to Fox News Digital.
Eli Lilly officials presented clinical trial results showing that a drug called donanemab slowed the cognitive and functional decline of people with mild cognitive impairment due to early-stage Alzheimer’s. (iStock)
He added, “Treatments are progressing. We now need more types of treatments, that target different aspects of the disease, and with greater efficacy and safety.”
“A richer and stronger life without the threat of memory loss, confusion or cognitive decline — that’s what we envision.”
The next step toward approval of donanemab is FDA review.
Dr. Mark Siegel, a clinical professor of medicine at NYU Langone Medical Center, said donanemab is very similar to Lekambi, the current drug on the market that blocks amyloid formation. (Dr. Mark Siegel)
Dr. Mark Siegel, Clinical Professor of Medicine NYU Langone Medical Center And a Fox News medical contributor who was not involved in the drug trials said donanemab is very similar to Lekambi, the current drug on the market that blocks amyloid formation.
“A richer and stronger life without the threat of memory loss, confusion or cognitive decline — that’s what we envision.”
“The problem with denonumab is similar — it can cause swelling and bleeding in the brain,” Siegel told Fox News Digital.
“It’s expensive too, because in Lekambi it’s once a month, whereas here it’s once every two weeks.”
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Siegel said denonumab is “somewhat more effective,” because it slows Alzheimer’s progression by about 35%, compared with 27% for Lakambi.
“It may be better at removing plaque,” he said.
“A future with more approved treatments for Alzheimer’s is a huge advancement for people eligible for these medications,” said the president and CEO of the Alzheimer’s Association in a statement. (iStock)
However, there may be limitations associated with these types of medications, doctor,
“A number of experts have told me that the obsession with amyloid formation is probably not the sacred goal it was once believed to be,” Siegel told Fox News Digital.
“The study did not pay enough attention to the tau protein, which also plays a major role here.”
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Tau proteins, which form “tangles” in the brains of Alzheimer’s patients, are not the primary target of these drugs, Siegel said.
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“There is also the issue of neuroinflammation and neuronal transmission abnormalities, which precede the build-up of plaque proteins and are important targets for research.”
Fox News Digital has reached out to Eli Lilly and the FDA for comment.
