US FDA Grants Advanced Nod to Genfit and Ipsen's Liver Disease Drug

The U.S. Food and Drug Administration has granted advanced approval to the French drugmakers Ipsen and Genfit for their drug Iqirvo, which treats a chronic inflammatory liver disease called primary biliary cholangitis (PBC). PBC causes inflammation of the small bile ducts in the liver and eventually destroys them. It primarily affects women aged 30 to 60 and impacts 75,000 people in the United States.

According to Ipsen, a month's supply of Iqirvo costs approximately $11,500, and it is already available for healthcare providers to prescribe in the United States. Ipsen added that standard endorsement for Iqirvo might be dependent upon confirmatory trials, as progress in endurance or counteraction of liver decompensation occasions that can incorporate abdominal swelling or gastrointestinal bleeding was not illustrated.

Ocaliva from Intercept Pharmaceuticals is approved for use in PBC patients as a monotherapy or in combination with ursodeoxycholic acid (UDCA) in patients who are unable to tolerate UDCA. Based on this approval, Iqirvo will also be used in similar ways. Based on data from a 161-patient late-stage clinical trial, Iqirvo was approved because it reduced levels of an enzyme known as alkaline phosphatase, which can damage the liver.

According to Christelle Huguet, Executive Vice President at Ipsen, it works by activating specific receptors, which promote detoxification, increase bile acid transport outside the liver, and reduce inflammation.