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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Americans consume foods every day that are marketed as “healthy,” when they could be quietly destroying their health, one doctor warns.
Dr. Mark Hyman, physician and co-founder of Function Health in California, says that much of America’s daily diet is filled with unhealthy ingredients.
“The amount of refined starches and sugars that are everywhere is just staggering to me, given what we know about how harmful they are,” he shared in an interview with Fox News Digital. “I don’t think people really understand.”
Hyman, author of the new book “Food Fix Uncensored,” said he’s “astounded” by what people are eating, especially for breakfast.
“People just eat sugar for breakfast,” he said. “They have muffins, they have bagels, they have croissants, they have sugar-sweetened coffees and teas.”
Dr. Mark Hyman is the author of the new book “Food Fix Uncensored.” (Function Health; Little, Brown Spark)
In addition to the traditionally sweet options for breakfast, some cereal brands and breakfast staples have adopted new “protein-packed” menu items and products, following health trends that encourage eating more protein.
“Highly processed food is not food.”
“Now, we’re seeing this halo of protein in certain things,” Hyman said, mentioning that many protein smoothies are “full of sugar.”
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The doctor also noted that some popular cereals are now marketed as having protein in them. “My joke is, if it has a health claim on the label, it’s definitely bad for you,” he said.
Instead of starting the day with a “quick fix” or processed food, Hyman suggests choosing whole sources of protein and fat for breakfast, adding that “if there’s a little carbohydrate in there, it’s fine.”
More products marketed as “high protein” have cropped up on supermarket shelves. (iStock)
For his own breakfast, Hyman said he has a protein shake with whey protein, avocado and frozen berries. Eggs and avocados are also a great protein-and-fat combo option, he added.
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“It’s not that complicated — people need to just think about their breakfast not being dessert,” he said. “No wonder we’re in this cycle of obesity and diabetes. One in three teenage kids now has type 2 diabetes or pre-diabetes. That’s just criminal.”
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Instead of counting calories and being in a caloric deficit as a way to lose weight and stay healthy, Hyman instead suggests focusing on how certain foods make you feel and how they impact your health.
“When you look at the way in which different types of calories affect your biology, you can just choose what you’re eating, and then you don’t have to worry about how much,” he told Fox News Digital.
In addition to the traditionally sweet options for breakfast, some cereal brands and breakfast staples have adopted new “protein-packed” menu items and products. (iStock)
“For example, if you eat a diet that doesn’t cause your insulin to spike — which is low in starch and sugar, higher in protein and fat — you won’t develop those swings in blood sugar, you won’t develop the spikes in insulin, you won’t deposit hungry fat … You will break that cycle.”
People are more likely to “self-regulate when they eat real food” instead of processed foods, which “bypasses the normal mechanisms of satiety, fullness and brain chemistry,” according to Hyman.
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“Ultraprocessed food and junk food or highly processed food is not food,” he said. “It doesn’t support the health and well-being of an organism. It doesn’t do that. It does the opposite.”
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Small fragments of plastic were found in the tumors of most prostate cancer patients, according to a new study from NYU Langone Health.
In past studies, microplastics have been found in almost every human organ and in bodily fluids, but their impact on human health still isn’t fully understood.
The researchers analyzed tissue samples from 10 patients with prostate cancer who underwent surgery to remove the entire organ.
Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples, according to the study press release.
In past studies, microplastics were found in almost every single human organ along with bodily fluids, even the placenta. (iStock)
The cancerous tissue contained on average more than double the amount of plastic as healthy prostate tissue samples, the study found. This equates to about 40 micrograms of plastic per gram of tissue compared to 16 micrograms.
Researchers avoided contaminating the samples with other plastics by substituting standard tools with those made of aluminum, cotton and other non-plastic material, the release noted.
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The scientists say this is the first direct evidence linking microplastics to prostate cancer.
“By uncovering yet another potential health concern posed by plastic, our findings highlight the need for stricter regulatory measures to limit the public’s exposure to these substances, which are everywhere in the environment,” said senior study author Vittorio Albergamo, assistant professor in the department of pediatrics at NYU Grossman School of Medicine, in the release.
Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples. (iStock)
The study findings were presented during the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco on Feb. 26.
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“What is most striking is not that microplastics were detected, but that they were found embedded within tumor tissue itself,” Dr. David Sidransky, oncologist and medical advisor at SpotitEarly, a startup that offers an at-home breath-based test to detect early-stage cancer, told Fox News Digital.
“While complete avoidance is unrealistic, people can take practical steps to reduce exposure.”
“We already know microplastics are present in water, air, blood and even placental tissue. Their detection in prostate tumors suggests systemic distribution and long-term bioaccumulation,” added Maryland-based Sidransky, who was not involved in the study.
Study limitations
Albergamo cautioned that a larger sample is needed to confirm the findings. Additionally, Sidransky noted that the presence of microplastics alone does not prove they cause cancer.
“Tumors can act as ‘biologic sinks,’ meaning they may accumulate circulating particles simply because of altered vasculature and permeability,” he said.
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A key unanswered question, according to the doctor, is whether microplastics are biologically active in ways that “promote DNA damage, immune modulation or chronic inflammation within the prostate.”
About one in eight men in the U.S. will be diagnosed with prostate cancer at some point in their lifetime, according to the Centers for Disease Control and Prevention.
The most actionable step men can take is appropriate screening and early detection, according to doctors. (iStock)
For those concerned about microplastics, Sidransky offered some insights.
“I believe the appropriate response is curiosity, not panic, and a commitment to understand more,” he said.
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“While complete avoidance is unrealistic, people can take practical steps to reduce exposure, such as minimizing heating food in plastic containers, reducing bottled water consumption when possible, and favoring glass or stainless steel alternatives.”
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The most actionable step men can take, however, is getting appropriate screenings to help ensure early detection, according to the doctor. Screening discussions should be individualized based on age, family history and other risk factors.
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