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

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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.

"Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed," an Eli Lilly and Company spokesperson told Fox News Digital in an email.

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

"The potential to complete Kisunla treatment after a limited-duration course of therapy based on amyloid pathology, along with 30-minute infusions once per month, could mean lower patient out-of-pocket treatment costs and reduced infusion burden compared to other amyloid-targeting therapies."

Kisunla demonstrated "very meaningful results" for people with early symptomatic Alzheimer's disease, noted Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company, in a press release.

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"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," she added.

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.

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

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.

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

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. (iStock)

Charles Bernick, M.D., staff neurologist at Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nevada, noted that donanemab is in a class of drugs termed "monoclonal antibodies."

"Antibodies are produced by the immune system and allow removal of specific toxins from the body," Bernick told Fox News Digital.

"Donanemab is an antibody that specifically targets the amyloid plaques that occur in Alzheimer's disease and causes their removal. Studies show that removal of the plaques by donanemab can slow progression of the disease."

"The group that responded the best were those with the mildest symptoms."

Bernick reiterated that donanemab is intended to be prescribed in individuals with mild symptoms of Alzheimer's disease, either those who are still functioning independently or only need slight assistance. 

"In fact, the group that responded the best were those with the mildest symptoms," he added. "It is not indicated for people with more advanced symptoms of Alzheimer's disease."

Leqembi, the first drug to show that it slows Alzheimer’s, was approved by the U.S. Food and Drug Administration in early January 2023. (AP Photos)

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

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.

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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.

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.

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)

Both donanemab and lecanemab are effective at removing amyloid plaques from the brain, Bernick told Fox News Digital.

"They differ primarily in that donanemab is given by infusion once a month, whereas lecanemab is twice a month," he said. 

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"In addition, the recommended treatment course of lecanemab is 18 months, but donanemab is given only up to the point when the amyloid plaque is removed and then is stopped, even if this occurs at six or 12 months."

Given that it is only given once a month and is stopped once plaque is removed, both the financial cost and burden of infusions are likely less with donanemab, according to Bernick.