11 Jun 2024
The U.S. Food and Drug Administration has granted accelerated approval to Iqirvo, a drug developed by French pharmaceutical companies Ipsen and Genfit, for treating primary biliary cholangitis (PBC), a chronic inflammatory liver disease. The companies announced the approval on Monday.
Primary biliary cholangitis, which primarily affects women aged 30 to 60, causes inflammation and eventual destruction of the small bile ducts in the liver, impacting around 75,000 people in the United States. Iqirvo, priced at approximately $11,500 for a month's supply, is now available for healthcare providers to prescribe in the U.S.
Ipsen noted that standard approval for Iqirvo might be dependent on confirmatory trials, as the drug has not yet demonstrated improvement in survival rates or prevention of liver decompensation events, such as abdominal swelling or gastrointestinal bleeding.
Iqirvo's approval is based on data from a late-stage trial involving 161 patients, where it successfully reduced levels of alkaline phosphatase, an enzyme associated with liver damage. The drug operates by activating specific receptors that reduce inflammation, enhance bile acid transport out of the liver, and promote bile acid detoxification, explained Christelle Huguet, Executive Vice President at Ipsen.
Unlike current treatments, which do not address liver inflammation or scarring, nor promote bile acid detoxification, Iqirvo also showed improvement in reducing itchy skin—a common PBC symptom—over placebo in the study. Other treatments like Intercept Pharmaceuticals’ Ocaliva can worsen itching.
Ipsen acquired global rights to license Iqirvo from Genfit in 2021, with Genfit receiving 120 million euros ($129.19 million) upfront and eligible for up to 20% in royalties. Meanwhile, Gilead is also developing a drug for PBC, with an FDA decision expected in August.
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