United States: The release of a new drug that has a function in slowing the advancement of liver disease has been approved.
Ipsen, a French pharmaceutical firm, has recently obtained approval from the Us Food and Drug Administration (FDA) to market their drug called Iqirvo, that is scientifically known as elafibranor.
The drug being developed is an 80 mg tablet taken orally at a single daily dose, and it is planned to be used to treat autoimmune cholestatic liver disease – primary biliary cholangitis (PBC).
Know more about PBC
PBC is an autoimmune disease whose hallmark is the attack on the small biliary tracts of the liver by individuals’ immune systems.
However, should these acids fail to be exported through the bile ducts, they may leak unto the surrounding tissue, thereby exerting negative influences on this vital organ and may contribute to liver failure according to the NIH.
Should the bile ducts be inactive, these acids can spill over into the surrounding tissue, where they result in liver injury or failure, as expounded by the NIH.
Cholestasis, together with other chronic processes, inflammation, and indecorous stagnation, is a part of this disease, which results in the scarring of the liver and the growth of bile ducts.
However, according to some health experts, while the PBC is still diagnosed as a rather uncommon disease, it can remain rather unnoticed.
According to Dr. Douglas Dieterich, M.D., director of the Institute for Liver Medicine at Mount Sinai Health System in New York City, “PBC is likely to be way underdiagnosed,” as Fox News reported.
Diagnosis of PBC
PBC is confirmed by a test called the liver function test, which checks for the levels of liver enzymes in the blood.
One common test measures the level of the substance called alkaline phosphatase (ALP), which is known to be instrumental in revealing the presence of liver or bone disorders.
Another blood test to detect PBC is the one for antimitochondrial antibodies, and AMAs are positive in almost 95 percent of the patients with this disease, according to several experts in liver diseases.
Experts review
According to Dieterich of New York City, who is also a professor of medicine at the Icahn School of Medicine at Mount Sinai, this newly formed medication “is a giant step forward in the treatment of PBC.”
He added, “Up until now, there has been only one drug available … Now there are two.”
The currently available drug, ursodeoxycholic acid (UDCA), whose common name is ursodial or “urso” is a naturally occured bile acid, which is being used for the treatment of liver disease for decades.
However, the recently approved Iqirvo (elafibranor) would replace UDCA when administered as monotherapy in patients who cannot respond optimally to UDCA and may be used together with UDCA when the latter is given as a monotherapy, and the patient’s condition does not improve sufficiently.
According to Christelle Huguet, executive vice president and head of research and development at Ipsen, “For a significant number of people living with PBC, available treatments do not control the condition and may exacerbate symptoms of PBC,” as Fox News reported.
“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,” Huguet added.