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Ipsen SA (OTC:IPSEF) (OTC:IPSEY) announced Monday that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets to treat primary biliary cholangitis (PBC).
PBC is a rare, autoimmune, cholestatic liver disease where a build-up of bile and toxins and chronic inflammation causes irreversible fibrosis of the liver and destruction of the bile ducts.
This drug is approved for use with ursodeoxycholic acid (UDCA) or as a standalone treatment in cases where UDCA is not tolerated.
Iqirvo is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed from GENFIT S.A. (NASDAQ:GNFT) in 2021.
The expedited approval is based on the medication’s ability to reduce levels of alkaline phosphatase (ALP), an indicator of liver health.
Continued approval will depend on further verification in confirmatory trials. The approval of Iqirvo follows promising results from the Phase III ELATIVE trial, which was published in the New England Journal of Medicine.
The study found that patients treated with Iqirvo, in addition to UDCA, were 13 times more likely to achieve a primary biochemical response compared to those receiving a placebo.
Iqirvo, developed by Genfit and commercialized by Ipsen, is now available for prescription in the U.S., offering a new therapeutic option for treating PBC.
In 2024, GENFIT anticipates substantial milestone payments from Ipsen totaling approximately €89 million, which include €48.7 million expected from the initial U.S. sales of Iqirvo.
PBC impacts approximately 100,000 people in the U.S. and is growing globally. If inadequately treated, it can cause liver failure.
Christelle Huguet, Executive Vice President, Head of Research and Development at Ipsen, said, “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.”
Iqirvo is priced at approximately $11,500 for a monthly supply, Reuters reported.
Price Action: GNFT shares are trading lower by 1.45% at $5.50 in premarket at the last check Tuesday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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