By Puyaan Singh and Mariam Sunny

June 10 (Reuters) - The U.S. Food and Drug

Administration granted accelerated approval to French drugmakers

Ipsen and Genfit's drug for a chronic

inflammatory liver disease, Iqirvo, the companies said on

Monday.

Primary biliary cholangitis (PBC) causes inflammation of the

small bile ducts in the liver and eventually destroys them. It

primarily affects women aged 30 to 60, impacting 75,000 in the

United States.

Iqirvo's estimated price is $11,500 for a month's

supply, and it is already available for healthcare providers to

prescribe in the U.S., Ipsen said.

Ipsen added that standard approval for Iqirvo may be

contingent on confirmatory trials, as improvement in survival or

prevention of liver decompensation events that can include

abdominal swelling or gastrointestinal bleeding was not

demonstrated.

Intercept Pharmaceuticals' Ocaliva is approved

for PBC patients in combination with ursodeoxycholic acid

(UDCA), or as a monotherapy in patients unable to tolerate UDCA.

Iqirvo is also to be used under similar conditions, based on

this approval.

Iqirvo's approval was based on data from a 161-patient

late-stage trial, in which it reduced levels of an enzyme called

alkaline phosphatase that can lead to liver damage.

It works by activating certain receptors, which reduce

inflammation, increases transport of bile acids outside the

liver and promotes their detoxification, said Christelle Huguet,

Executive Vice President at Ipsen.

Current treatments do not address inflammation or

scarring of the liver and do not promote detoxification of bile

acids, Huguet added.

In the study, Iqirvo also showed an improvement in itchy

skin - a symptom of PBC - over placebo. Other treatments such as

Ocaliva can worsen itching.

Ipsen acquired global rights to license the drug from

Genfit in 2021. Genfit received 120 million euros ($129.19

million) upfront and is eligible to receive double-digit

royalties of up to 20%.

Gilead is also developing a drug for PBC, on

which the FDA is expected to decide in August.

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