Health
FDA approves new drug to treat autoimmune liver disease: ‘Giant step forward’
A new drug to control liver disease has gotten the green light.
The U.S. Food and Drug Administration (FDA) has approved the French drugmaker Ipsen’s medication Iqirvo (elafibranor).
The drug, an 80 mg tablet administered orally once daily, is intended to treat an autoimmune cholestatic liver disease called primary biliary cholangitis (PBC).
What is PBC?
PBC is a disease in which the immune system attacks and destroys the small bile ducts of the liver.
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Without the active bile ducts, acids can then leak into the nearby tissue and cause liver damage or failure, according to the National Institutes of Health (NIH).
The U.S. Food and Drug Administration (FDA) has approved the French drugmaker Ipsen’s medication Iqirvo (elafibranor). (iStock)
The disease typically involves chronic inflammation along with a stagnant build-up of bile and toxins known as cholestasis, which can lead to irreversible scarring of the liver and ultimately destroy the bile ducts.
Although PBC is considered a rare condition, it can often go undetected, some health experts said.
“PBC is likely to be way underdiagnosed,” Dr. Douglas Dieterich, M.D., director of the Institute for Liver Medicine at Mount Sinai Health System in New York City, told Fox News Digital.
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“Many people — mostly women — have elevated liver enzymes that can be easily diagnosed with a simple blood test called the AMA.”
Patients typically experience severe fatigue and significant itching called pruritus.
If the disease is not treated or an individual does not respond to current therapies, it can lead to liver failure, the need for a liver transplant or even early death, according to experts.
PBC is a disease in which the immune system attacks and destroys the small bile ducts of the liver. Without the active bile ducts, acids can then leak into the nearby tissue and cause liver damage or failure. (iStock)
PBC is diagnosed with a blood test that measures liver enzymes.
One common test analyzes the patient’s alkaline phosphatase (ALP), an enzyme that helps detect liver or bone disease.
Another blood test to diagnose PBC measures antimitochondrial antibodies (AMAs), which are positive in approximately 95% of patients with the condition, according to several liver experts.
Patient welcomes more treatment options
One New York patient with PBC told Fox News Digital that she did not know she had a liver disease until her primary care physician performed routine blood work and noticed that her liver enzymes were elevated.
Meredith S., who withheld her last name for privacy reasons, was referred to a hepatologist, whom she credits for saving her life.
“It is distressing to know that your body is fighting itself and you can’t figure out how to stop it.”
“I was feeling tired, but attributed it to working and studying at school,” she told Fox News Digital.
“I was completely surprised to find out I had a liver disease and learned it was PBC.”
She went on, “My doctor performed a liver biopsy and I had significant scarring of my liver in my 30s, even though I didn’t drink alcohol.”
Patients have expressed relief at having another treatment option for liver disease. (iStock)
Meredith S. said she is glad there are more treatment options available, and hopes for more awareness and research of PBC.
“It is distressing to know that your body is fighting itself and you can’t figure out how to stop it,” she told Fox News Digital.
Addressing an ‘unmet need’
Dieterich of New York City, who is also a professor of medicine at the Icahn School of Medicine at Mount Sinai, told Fox News Digital that this newly approved medication “is a giant step forward in the treatment of PBC.”
He noted, “This is a giant step forward in the treatment of PBC. Up to now, there has been only one drug available to add to the urso, which is the basis for PBC treatment. Now there are two.”
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The existing drug, ursodeoxycholic acid (UDCA) — commonly called ursodial or “urso” — is a naturally occurring bile acid that has been used to treat liver disease for decades.
The newly approved Iqirvo (elafibranor) is intended to be used in combination with UDCA in patients who are not responding to the first medication on its own, or can be used on its own for people who cannot tolerate UDCA.
The disease typically involves chronic inflammation along with a stagnant build-up of bile and toxins known as cholestasis, which can lead to irreversible scarring of the liver and ultimately destroy the bile ducts. (iStock)
“For a significant number of people living with PBC, available treatments do not control the condition and may exacerbate symptoms of PBC,” said Christelle Huguet, executive vice president and head of research and development at Ipsen, in a press release.
“Iqirvo demonstrated statistically significant improvements in biochemical response compared to UDCA alone. Iqirvo is therefore a much-needed treatment option and the first new medicine for PBC in nearly a decade.”
Primary biliary cholangitis affects approximately 100,000 people in the U.S.
The accelerated approval for Iqirvo was based on positive results from the Phase III ELATIVE trial, which showed reduced levels of the alkaline phosphatase enzyme, which is elevated in people with liver disease.
The study, published in The New England Journal of Medicine, included 161 patients with PBC who were inadequately responding to treatment with UDCA or could not tolerate that medication.
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Researchers found that 51% of the patients who received the elafibranor had a biochemical response, compared to only 4% who received a placebo.
After 52 weeks, the patients who were treated with elafibranor showed normalized liver enzymes, compared to 15% of patients in the placebo group.
The study, which was published in The New England Journal of Medicine, included 161 patients with PBC. (iStock)
“Data from the pivotal Phase III ELATIVE clinical trial demonstrated that Iqirvo is an effective second-line treatment for patients with PBC with favorable benefit and risk data,” Dr. Kris Kowdley, a primary investigator on the ELATIVE study and the director at Liver Institute Northwest, Washington, said in a news release.
“The approval of Iqirvo will allow health care providers in the U.S. to address an unmet need, with the potential to significantly reduce ALP levels for our patients with PBC,” he added.
Continued approval is contingent upon further studies showing improved survival or prevention of liver decomposition, the FDA report noted.
Potential side effects and limitations
Some reported side effects of Iqirvo included muscle pain, rhabdomyolysis, myopathy, fractures, weight gain and drug-induced liver injury, according to the FDA report.
Some reported side effects of Iqirvo included muscle pain, rhabdomyolysis, myopathy, fractures, weight gain and drug-induced liver injury, according to the FDA report. (iStock)
Also noted was the potential risk to the fetus in pregnant patients, based on animal study data.
The FDA cautioned health care providers to ensure that patients are not pregnant prior to starting the medication.
Iqirvo is also not recommended in patients who have advanced stages of cirrhosis.
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Primary biliary cholangitis affects some 100,000 people in the United States, according to the drugmaker Ipsen.
It is a lifelong disease that can result in liver failure if left untreated, according to experts.
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Older adults identified as “super movers” are about half as likely to develop cognitive impairment than their peers.
That’s according to a recent study led by Stony Brook Medicine in New York, which evaluated the cognitive function of 4,000 adults 80 and over who participated in multiple aging and longevity studies over several years.
Among this group, 6% to 10% were classified as super movers, which means they walk at a much faster pace than others of the same age and gender — at speeds comparable to people three decades younger.
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The super movers were found to have about half the risk of cognitive decline compared to seniors with typical gait speed.
The findings were published in the journal Neurology on June 16.
Older adults identified as “super movers” are about half as likely to develop cognitive impairment than their peers. (iStock)
“The study reinforces that mobility and brain health are closely connected,” lead study author Dr. Joe Verghese, MD, neurologist at Stony Brook Medicine, told Fox News Digital. “This suggests that preserving mobility may be an important marker of healthy brain aging and resilience.”
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The most intriguing finding, according to Verghese, was that super movers maintained cognitive function despite having similar dementia-related brain changes as their peers.
In postmortem brain analysis, there was no difference in dementia-related pathologies between the super movers and the slower walkers, the study stated.
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“This suggests they may possess resilience mechanisms that help preserve brain function even in the presence of age-related changes,” he said. “Understanding these resilience factors could lead to new strategies for promoting healthy brain aging.”
As the study was observational, there were some limitations, and it does not prove that walking faster prevents dementia, the researchers noted.
Super movers were found to have about half the risk of cognitive decline compared to seniors with typical gait speed. (iStock)
“Other factors, such as cardiovascular health, physical fitness or genetics, may also contribute to both faster walking and better cognitive outcomes,” Verghese said.
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This study adds to growing evidence that what’s good for the heart and muscles also benefits the brain, he noted, adding that “staying physically active remains one of the most effective, evidence-based ways to support healthy aging.”
“Walking speed is best viewed as a marker of overall health, not a treatment.”
“The broader message is that physical activity is important at any age,” Verghese said. “Walking is an easy step-up point because you don’t need any special equipment. You can do it inside or outdoors, and you can do it on a regular basis. You can walk with a dog, you can walk with a friend.”
Any activity is beneficial if it’s done regularly and with the right intensity, he added.
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Rather than just trying to walk faster, the neurologist recommends that seniors focus on maintaining mobility through regular physical activity, strength training, balance exercises and good cardiovascular health.
“Walking speed is best viewed as a marker of overall health, not a treatment,” Verghese noted.
Major public health guidelines from the CDC and U.S. Physical Activity Guidelines recommend at least 150 minutes of moderate-intensity aerobic activity each week, such as brisk walking.
Major public health guidelines from the CDC and U.S. Physical Activity Guidelines recommend at least 150 minutes of moderate-intensity aerobic activity each week, such as brisk walking. (iStock)
This can be achieved by walking 30 minutes a day, five days a week, or about 20 to 25 minutes most days. Another option is to engage in shorter sessions that add up over the day.
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“You have to do it within your health limitations and medical conditions,” Verghese advised. “So if there are any medical concerns, I would get your physician to clear you before starting exercise.” The good thing about walking, he added, is that you can start at a slow pace and then gradually build up to a brisker pace.
“And then adding on strength and balance training, whatever age you are, I think is also important.”
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Health
Dr Oz warns Medicare scammers are stealing billions — and your personal information could be next
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Washington, D.C. – Medicare fraud is a multibillion-dollar problem that government officials say threatens both taxpayer dollars and Americans’ personal identities.
In a July 6 interview with Fox News Digital at the Great American State Fair in Washington, D.C., Dr. Mehmet Oz warned that every dollar stolen through Medicare fraud is a dollar taxpayers lose – a problem that has worsened since the COVID pandemic.
“If I had to just pick one thing to focus on to make healthcare more affordable in America, I’d go to health fraud and all the waste and abuse that accompanies it,” said Oz, who is the administrator of the Centers for Medicare & Medicaid Services. “And just to put this in perspective, we think it’s about $100 billion a year.”
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Medicare fraud can include billing for services that were never provided, overcharging for medical equipment, using stolen patient or doctor information, or performing unnecessary procedures, according to the U.S. Government Accountability Office.
CMS administrator Dr. Mehmet Oz is pictured on stage at the Great American State Fair in Washington, D.C., on July 6, 2026. (Angelica Stabile/Fox News Digital)
As the Trump administration ramped up efforts to combat fraud, CMS reported $41.9 billion in Medicare program integrity savings in 2025, up 59% from $26.3 billion in 2024.
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Medicare fraud not only harms the federal budget and steals from taxpayers, but exposes seniors to identity theft, unnecessary care, higher premiums and reduced access, Oz cautioned.
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Removing corruption from the healthcare system will have the greatest impact among seniors, since “so much of the fraud is perpetrated against them,” the administrator said.
“I’m talking about people tricking seniors to give up their Medicare beneficiary numbers, which is like a credit card basically,” he said. “These scammers can take those numbers and use them for all kinds of illegitimate purposes.”
“If I had to just pick one thing to focus on to make healthcare more affordable in America, I’d go to health fraud and all the waste and abuse that accompanies it,” said Oz. (Fox News Digital)
“People are stealing from you by pretending to send you drugs you don’t want, wheelchairs you don’t need, [and] services you never asked for or don’t benefit from,” Oz added.
To prevent this, he shared his top advice for seniors: Do not give your Medicare beneficiary number to anybody, do not answer questions on a phone call from an unknown person and do not give away personal information.
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“These scammers are calling seniors, tricking them, and once they have key information, they can steal it,” he said. “And I won’t know it and you won’t know it.”
“We want to protect people who need these programs the most,” Oz went on. “You do that by making sure scoundrels don’t corrupt the systems and steal money out of the till that is designed to help folks in dire straits when they’re vulnerable and in need of services.”
Seniors should never share their Medicare information with unknown people, the administrator advised. (iStock)
Removing fraud could “double the life expectancy of the trust fund that makes all this possible,” Oz predicted.
“If you’re worried about Medicare being there when you’re ready to retire in a couple decades, depending on how old you are, and you’re concerned that it might not last because of all the fraud that’s hitting it … you’ve got a good [reason to] worry,” he said.
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“If we take the fraud out, we could double the life expectancy, which means you, your kids, your kids’ kids … they could all benefit from this beautiful safety net program.”
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