Experimental Alzheimer’s drug gets FDA advisory panel's thumbs-up: ‘Progress is happening’

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.

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.

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. 

"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 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. 

"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.

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. 

"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."              

Fox News Digital reached out to Eli Lilly and the FDA requesting comment.

Billy Ray Cyrus files for annulment alleging inappropriate marital conduct after 7-month marriage

Billy Ray Cyrus and Firerose are calling it quits on their relationship less than one year into their marriage.

Cyrus, 62, filed for an annulment from the Australian singer, 36, in May citing "irreconcilable differences" and alleged "inappropriate marital conduct," according to documents obtained by Fox News Digital.

The "Achy Breaky Heart" country crooner submitted a petition to end their union in a Tennessee court last month.

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In addition, the grounds for annulment were listed as "consent to marriage was obtained by fraud." Their date of separation was listed as May 22, 2024, documents stated.

"Husband charges that he is entitled to an annulment since he gave consent to marriage based on fraud by the wife, that had he known he would not have entered into the bonds of matrimony with his wife," the petition stated.

Representatives for Cyrus did not immediately respond to Fox News Digital's request for comment.

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In an order filed May 24, Cyrus agreed to pay $500 per night for a period of 10 nights so that Firerose may "stay at a hotel or Airbnb while she searches for a place to reside during these proceedings." 

"Thereafter, husband shall pay wife $5,000 per month for the wife to obtain suitable housing in the middle Tennessee area for a period of 90 days or the dissolution of the marriage, whichever comes first," documents stated.

Cyrus must give "reasonable access" to their marital home to allow Firerose to move her belongings out, and she must provide all of his social media passwords to an appointed person, per the agreement. 

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The former couple married on his property in Tennessee in October, sharing on Instagram at the time that, "10/10/23 will always be the beautiful, joyous day that our two souls united as one in holy matrimony.

"It was the most perfect, ethereal celebration of love we could have ever imagined."

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Cyrus and Firerose, whose full name is Johanna Rosie Hodges, announced their engagement in November 2022. 

At the time, Cyrus revealed to People magazine that he first met his future bride 13 years ago on the set of "Hannah Montana."

"There's a couple old pine trees on the lot that look like Tennessee," he recalled. "Tex (his dog) and I would go out there in the middle of the day, and he'd take care of his business. And we'd stretch, and I'd think how much I missed Tennessee. 

"On that given day, Firerose came out of the front door. There was almost a moment of, I don't know, recognition. I was like, 'This girl's a star.'"

Cyrus has five children with ex-wife Tish Cyrus. Firerose was also previously married.

Fox News Digital has reached out to a rep for Billy Ray for comment.

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