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 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.

While some people might have experienced the feeling of “being drunk” the morning after they consumed excessive amounts of alcohol, is it possible to feel intoxicated without ever drinking an alcoholic beverage?

Although it’s extremely rare, experts say it can happen.

The phenomenon is called auto-brewery syndrome, or ABS, according to Dr. Douglas Dieterich, M.D., director of the Institute for Liver Medicine at the Mount Sinai Health System in New York City.  

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The syndrome occurs when a patient’s gut gets colonized by a fungus that metabolizes carbohydrates and sugar into alcohol through fermentation, the doctor told Fox News Digital.

Before diagnosing a patient with ABS, Dieterich said that doctors “should always rule out other causes and make sure the patient is not drinking surreptitiously.”

Here’s a deeper dive.

A real-life case of auto-brewery syndrome

In one recent case study published in the Canadian Medical Association Journal, a 50-year-old woman had not consumed alcohol. Yet she continually had symptoms associated with intoxication, including the smell of alcohol on her breath, slurred speech and elevated blood alcohol levels during several emergency department visits. 

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The woman had a history of recurrent urinary tract infections that were treated with several courses of antibiotics, along with medications to reduce stomach acid.

Eventually the patient was diagnosed with auto-brewery syndrome, according to the published report.

In a recent case study, a woman (not pictured) continually showed symptoms associated with intoxication, including having the smell of alcohol on her breath, slurred speech and elevated blood alcohol levels — even though she had not consumed alcohol. (iStock)

“ABS carries paramount medical, legal, social and financial consequences for patients and their loved ones,” Dr. Rahel Zewude, lead author of the study and an infectious diseases and microbiology fellow at University of Toronto in Canada, told Fox News Digital.

“Therefore, awareness of this rare syndrome in the medical community, as well as in the general public, can be instrumental in reducing delays in diagnosis.”

“ABS carries paramount medical, legal, social and financial consequences for patients and their loved ones.”

The woman in the case study saw her physician and visited the emergency department at least seven times over a two-year period. She complained of excessive sleepiness, slurred speech, falls and alcohol smells on her breath.

During her first ED visit, she was diagnosed with alcohol intoxication after having an elevated blood alcohol limit at 39 mmol/L (normal is 2 mmol/L or less) — despite her reports of not consuming alcoholic drinks, which family members verified.

The woman’s liver enzymes were normal and a computed tomography (CT) scan of her head revealed no acute findings, the study said.

The woman was diagnosed with alcohol intoxication after having an elevated blood alcohol limit at 39 mmol/L (normal is 2 mmol/L or less) — despite not consuming alcoholic drinks. (iStock)

Throughout the woman’s various visits to the emergency department, three psychiatrists provided addiction-related care, even though she scored a zero on the CAGE (Cut, Annoyed, Guilty and Eye) screening test, which assesses patients for alcohol use disorder.

(A total score of 2 or higher is considered clinically significant, according to the American Addiction Centers website.)

After experiencing episodes every one to two months, the woman was diagnosed — upon her seventh visit to the ED — with possible auto-brewery syndrome. She was prescribed an antifungal medication called fluconazole and referred to a gastroenterologist.

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She completed a one-month course of fluconazole and adhered to a low-carb diet — and her symptoms began to resolve. 

After four months, though, symptoms began to come back when she ramped up her carbohydrate intake, the study said.  

“A sugar-free, low-carb diet has been shown to be effective in managing symptoms — the fewer carbohydrates ingested, the less chance that carbohydrate fermentation will occur in the gut,” an expert advised. (iStock)

After another course of fluconazole and a return to a low-carb diet, the symptoms resolved. 

A course of probiotics was also prescribed to help foster better gut health.

What makes a person susceptible to ABS?

Several factors contribute to ABS, according to Zewude. 

“The disease likely presents when these factors emerge simultaneously alongside a high-carbohydrate diet,” she told Fox News Digital.

One of the main factors is disruption of the gut microbiome, which is the population of microorganisms in the gut.

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“In ABS, the fungi that ferment alcohol overpopulate our gut ahead of other non-fermenting bacteria,” Zewude said. 

“This gut microbiome disruption can occur due to frequent or prolonged courses of antibiotics.”

One of the main factors in ABS is disruption of the gut microbiome, which is the population of microorganisms in the gut. “In ABS, the fungi that ferment alcohol overpopulate our gut ahead of other non-fermenting bacteria,” the study author said.  (iStock)

Diabetes as well as gastrointestinal illnesses such as Crohn’s, liver disease and ulcerative colitis can also be risk factors for ABS, Zewude said. 

Genetic predispositions that affect how the body metabolizes and clears ethanol can also play a role.

Testing for and treating ABS

One way to test for ABS is to perform an oral glucose challenge in a supervised setting, where a patient first measures their fasting blood alcohol level. 

This baseline level should be undetectable if the person had fasted for eight hours and did not consume any alcohol, according to Zewude.

“Diet modification is an extremely important part of reducing or resolving symptoms of auto-brewery disease.”

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The patient then ingests a high load of glucose, and their alcohol level is measured in 30-minute, one-hour, two-hour, four-hour, eight-hour and 24-hour increments.

“If their alcohol level begins to rise after ingestion of glucose, that can help confirm gut fermentation of alcohol from carbohydrates, which is ABS,” Zewude told Fox News Digital. 

Although ABS has been described in medical literature for over 50 years, the condition still remains misunderstood, with limited information regarding diagnosis and treatment, according to health experts. (iStock)

The test should be conducted in a monitored clinic to ensure that the patient is not consuming alcohol, and to ensure safety in the event that the patient does become intoxicated, the expert advised.

The rare condition requires a multidisciplinary approach that may include a liver specialist or gastroenterologist, primary care physician, infectious diseases specialist and registered dietitian, health experts told Fox News Digital. 

It is typically treated with antifungal medications and a low-carb diet, as noted in the case study mentioned earlier.

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“Diet modification is an extremely important part of reducing or resolving symptoms of auto-brewery disease,” Simone Gmuca, a registered dietitian who works with patients in Douglaston, New York, told Fox News Digital.

Patients with ABS should also incorporate plenty of lean meats, fish, avocados, olive oil, nuts, seeds and leafy green vegetables into their diet, experts recommended. (iStock)

“A sugar-free, low-carb diet has been shown to be effective in managing symptoms — the fewer carbohydrates ingested, the less chance that carbohydrate fermentation will occur in the gut,” added Gmuca, who was not affiliated with the study.

Patients should avoid simple carbohydrates like breads, pastas, crackers, sugary beverages, potato chips and fruit juices during treatment, the doctor said.

“Increasing lean protein, heart-healthy fats and low-starch vegetables can help promote satiation and reduce the risk of nutrient deficiencies,” Gmuca added.

The condition known as ABS requires a multidisciplinary approach that may include a liver specialist or gastroenterologist, primary care physician, infectious diseases specialist and registered dietitian, said health experts. (iStock)

Patients with ABS should also incorporate plenty of lean meats, fish, avocados, olive oil, nuts, seeds and leafy green vegetables into their diet, she recommended.

For more Health articles, visit www.foxnews/health 

Although ABS has been described in medical literature for over 50 years, the condition still remains misunderstood — with limited information regarding diagnosis and treatment, according to health experts.

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