FDA approves new drug for Alzheimer’s disease: ‘Meaningful results’

The U.S. Food and Drug Administration (FDA) has approved a new medication for people with Alzheimer’s disease. 

Eli Lilly’s Kisunla (donanemab) is a once-monthly injection intended for adults with early symptomatic Alzheimer’s disease, according to a press release from the company.

Eligible patients include those with mild cognitive impairment (MCI) and those who have mild dementia with confirmed amyloid pathology.

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This is the first medication to target amyloid plaques — the proteins that build up in the brains of Alzheimer’s patients, often impairing memory and cognitive function — with evidence to support stopping therapy when amyloid plaques are removed, the release stated.

The U.S. Food and Drug Administration (FDA) has approved a new medication for people with Alzheimer’s disease.  (iStock)

“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options,” said Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company, in the release.

“We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis.”

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Fox News Digital reached out to the company for further comment.

The drug is designed to remove excessive buildup of amyloid plaques and slow cognitive decline, according to the company.

The approval follows an advisory panel’s recommendation of the drug at the FDA’s Peripheral and Central Nervous System Advisory Committee hearing last month.

At that 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.

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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.

Eli Lilly’s Kisunla (donanemab) is a once-monthly injection intended for adults with early symptomatic Alzheimer’s disease. (iStock)

That study was published by the Journal of the American Medical Association.

The most serious potential side effect of Kisunla is amyloid-related imaging abnormalities (ARIA), which can lead to temporary brain swelling or bleeding.

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Although this effect “usually resolves over time,” it can be life-threatening, the company said.

Some patients may also experience headaches or potentially serious allergic reactions during or shortly after the drug’s infusion.

A doctor points out evidence of Alzheimer’s disease on PET scans at the Center for Alzheimer Research and Treatment at Brigham And Women’s Hospital in Boston, Massachusetts.  (REUTERS/Brian Snyder/File Photo)

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.

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Denonemab is “somewhat more effective,” Siegel noted, as it slows the progression of Alzheimer’s by about 35% versus 27% for Leqembi.

“It may be better at removing plaques,” he said.