By Puyan Singh and Mariam Sunny

London: The US Food and Drug Administration Quick Approval French drugmakers Ipsen and Genfit’Medicine for an old Inflammatory liver disease, Ikirvothe companies said on Monday.

primary biliary cholangitis (PBC) causes inflammation of the small bile ducts in the liver and eventually destroys them. It mainly affects women aged 30 to 60, with 75,000 people affected in the United States.

Ipsen said Ekirvo’s estimated cost is $11,500 for one month, and it is already available to healthcare providers in the U.S.

Ipsen said standard approval for Ekirvo may depend on confirmatory trials, as improvement in survival or prevention of liver damage events, which can include abdominal inflammation or gastrointestinal bleeding, had not been demonstrated.

Intercept Pharmaceuticals’ Ocaliva is approved for PBC patients in combination with ursodeoxycholic acid (UDCA) or as monotherapy in patients unable to tolerate UDCA. Based on this approval, Ekirvo is also to be used in similar conditions.

Ecyrvo’s approval was based on data from a late-stage trial involving 161 patients in which it reduced levels of an enzyme called alkaline phosphatase, which can damage the liver.

It works by activating certain receptors, which reduces inflammation, increases the transport of bile acids out of the liver and promotes their detoxification, said Christelle Huguet, executive vice president of Ipsen.

Current treatments do not address liver inflammation or scarring, and do not promote detoxification of bile acids, Huguet said.

In the study, Ekrivo also showed improvement in itchy skin — a symptom of PBC — compared with a placebo. Other treatments, such as Ocaliva, can make itching worse.

Ipsen acquired global rights to license the drug from Genfit in 2021. Genfit received an upfront payment of 120 million euros ($129.19 million) and is eligible to receive double-digit royalties of up to 20%.

Gilead is also developing a drug for PBC, which the FDA is expected to decide on in August. ($1 = 0.9289 euros) (Reporting by Puyan Singh and Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri and Alan Barona)