A major advancement in the treatment of autoimmune liver disease has been achieved with the FDA's approval of a new drug.

A new drug to control liver disease has gotten the green light.

Iqirvo (elafibranor), a medication developed by the French drugmaker Ipsen, has been approved by the U.S. Food and Drug Administration (FDA).

An 80 mg oral tablet of the drug is used to treat primary biliary cholangitis (PBC), an autoimmune cholestatic liver disease.

What is PBC?

The small bile ducts of the liver are destroyed by the immune system in PBC.

According to the NIH, liver damage or failure can occur when acids leak into nearby tissue due to the absence of active bile ducts.

Chronic inflammation and a build-up of bile and toxins known as cholestasis are common in the disease, which can cause irreversible scarring of the liver and destroy the bile ducts.

Some health experts said that although PBC is a rare condition, it can often go undetected.

Dr. Douglas Dieterich, M.D., director of the Institute for Liver Medicine at Mount Sinai Health System in New York City, believes that PBC is likely to be underdiagnosed.

"A simple blood test known as the AMA can easily diagnose elevated liver enzymes in many people, particularly women."

Patients typically experience severe fatigue and significant itching called pruritus.

Experts warn that if a disease is not treated or an individual does not respond to current therapies, it can result in liver failure, the need for a liver transplant, or even early death.

PBC is diagnosed with a blood test that measures liver enzymes.

An enzyme that helps diagnose liver or bone disease is analyzed through a typical test, which measures the patient's alkaline phosphatase (ALP) levels.

The diagnosis of primary biliary cirrhosis (PBC) can be confirmed through a blood test that detects antimitochondrial antibodies (AMAs), which are positive in about 95% of patients with the condition, according to multiple liver specialists.

Patient welcomes more treatment options

A New York patient with PBC discovered she had a liver disease after her primary care physician detected elevated liver enzymes during routine blood work.

Meredith S., who kept her last name private, was referred to a hepatologist and is grateful 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."

She informed Planet Chronicle Digital that she felt tired due to her schoolwork and studies.

"I was taken aback to discover I had a liver disease, which turned out to be PBC."

Despite not consuming alcohol, she had significant liver scarring in her 30s after her doctor performed a liver biopsy.

Meredith S. expressed her happiness about the increasing availability of treatment options for PBC and wished for greater awareness and research on the condition.

She told Planet Chronicle Digital that it was distressing to learn that her body was fighting against itself and she couldn't determine how to put an end to it.

Addressing an ‘unmet need’

Dieterich, a professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, told Planet Chronicle Digital that the newly approved medication represents a significant advancement in the treatment of PBC.

Until now, only one drug has been available; however, that has changed, and now there are two options.

For many years, ursodeoxycholic acid (UDCA), also known as ursodial or "urso," has been utilized to treat liver disease as it is a naturally occurring bile acid.

Elafibranor, the newly approved Iqirvo, can be used in combination with UDCA or on its own for patients who are not responding to UDCA or cannot tolerate it.

Ipsen's executive vice president and head of research and development, Christelle Huguet, stated in a press release that for many people with PBC, current treatments do not effectively manage the condition and may worsen symptoms.

"Iqirvo exhibited significant improvements in biochemical response compared to UDCA alone, making it a valuable treatment option and the first new medicine for PBC in over a decade."

Primary biliary cholangitis affects approximately 100,000 people in the U.S.

Iqirvo received accelerated approval due to the positive results from the Phase III ELATIVE trial, which demonstrated reduced levels of the alkaline phosphatase enzyme, which is elevated in individuals with liver disease.

A study published in The New England Journal of Medicine examined 161 patients with PBC who were not responding well to UDCA treatment or could not tolerate it.

A biochemical response was observed in 51% of elafibranor patients, compared to 4% of placebo recipients, according to research findings.

In contrast to 15% of patients in the placebo group, all patients who received elafibranor had normalized liver enzymes after 52 weeks.

According to Dr. Kris Kowdley, a primary investigator on the ELATIVE study and the director at Liver Institute Northwest, Washington, data from the pivotal Phase III ELATIVE clinical trial showed that Iqirvo is an effective second-line treatment for patients with PBC with favorable benefit and risk data.

With Iqirvo's approval, U.S. health care providers can address an unmet need, potentially reducing ALP levels for patients with PBC.

The FDA report stated that continued approval of the drug is dependent on additional research demonstrating enhanced liver survival or prevention of deterioration.

Potential side effects and limitations

The FDA report stated that some reported side effects of Iqirvo were muscle pain, rhabdomyolysis, myopathy, fractures, weight gain, and drug-induced liver injury.

Animal study data suggests that pregnant patients may face potential risks to their fetus.

Health care providers should verify that patients are not pregnant before administering the medication, as advised by the FDA.

Iqirvo is also not recommended in patients who have advanced stages of cirrhosis.

For more Health articles, visit www.Planet Chronicle/health

According to Ipsen, approximately 100,000 individuals in the United States are affected by primary biliary cholangitis.

Experts claim that this condition, which is a lifelong disease, can lead to liver failure if not treated.