Elafibranor

Iqirvo (elafibranor) has been conditionally approved in the EU for treating adults with primary biliary cholangitis (PBC), either with UDCA for non-responders or alone for those intolerant to UDCA. The approval is based on ELATIVE trial data showing Iqirvo reduced liver damage markers more than a placebo. Iqirvo activates PPAR alpha and delta receptors to control PBC-driving processes, offering a new treatment option for PBC patients.

The European Commission has conditionally approved Ipsen’s Iqirvo (elafibranor) for primary biliary cholangitis (PBC), the first drug for the liver disease in nearly a decade. The approval is for Iqirvo in combination with ursodeoxycholic acid in adults who do not respond adequately to ursodeoxycholic acid alone, or as a monotherapy for those unable to take ursodeoxycholic acid. The decision follows an accelerated approval by the FDA in June, based on Phase III ELATIVE trial data showing greater treatment benefits with Iqirvo plus ursodeoxycholic acid compared to a placebo.

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European Commission grants conditional marketing authorization for Iqirvo® (elafibranor), a first-in-class treatment for primary biliary cholangitis (PBC), following positive CHMP opinion based on ELATIVE phase III trial data. Iqirvo demonstrated significant efficacy over placebo and was well-tolerated, reinforcing Ipsen’s commitment to advancing medical innovations for rare cholestatic liver diseases.

GENFIT reports €61.6M cash and €59M revenues, including a €48.7M milestone for Iqirvo® (elafibranor) U.S. launch. Positive EMA opinion for Iqirvo in July 2024, with a potential €26.5M milestone upon European approval. CEO highlights Iqirvo's U.S. approval and anticipates European decision by year-end. ACLF franchise progresses, with VS-01 Phase 2 data expected in 2H24. MASH diagnostics recognized in new European guidelines. Corporate governance updates include new appointments. Financial outlook includes expected milestone revenue and strong financial position.

The FDA approved Gilead Sciences' Livdelzi for treating primary biliary cholangitis (PBC), a liver disease affecting mainly women. Priced at $12,606 for 30 days, it's expected to boost Gilead's liver drug portfolio. A study showed 62% improvement in biochemical response with Livdelzi and UDCA combination, and it significantly reduces itching, a common PBC symptom.