IPSEN, OOO

The European Commission approves Ipsen's IQIRVO (elafibranor) for primary biliary cholangitis, the first new therapy in the EU in a decade. Other companies, including CymaBay, Zydus, and GlaxoSmithKline, are preparing to enter the market. The approval is based on the Phase III ELATIVE trial, showing a 47% clinical benefit of IQIRVO combined with UDCA. Additionally, Gilead Sciences' LIVDELZI (seladelpar) received FDA accelerated approval for PBC.

Quanterix appoints Ivana Magovčević-Liebisch, Ph.D., J.D. to its Board of Directors, leveraging her 25+ years of biopharmaceutical experience, including founding Vigil Neuroscience and leading key strategic transactions at Ipsen and Teva.

AzurBio Pharma, headquartered in Paris, launches to bring innovative pharmaceutical products to European markets, focusing on rare and serious diseases. Offering strategic partnerships and flexible solutions for market entry, the company aims to streamline the process and accelerate time-to-market. Led by CEO Corinne Schmitz, AzurBio Pharma is supported by an elite strategic committee with deep expertise in biopharma and regulatory affairs.

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.

S.K., D.A.M., J.P., H.S., X.Z., P.H., T.X., and H.S. have financial ties to various pharmaceutical companies, including stock ownership and advisory roles. F.C., J.D., E.V.C., H.S.W., T.Y., R.Y., and J.T. also report consulting or advisory roles and research funding from multiple institutions and companies.

Regulatory snapshots: global drug submissions, approvals, clinical trial approvals, and other decisions involving Amplia, Apellis, Biocon, Biotech, Ipsen, Janssen, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Samsung Bioepis, Sanofi.

Ipsen's Kayfanda® (odevixibat) approved in the European Union for treating cholestatic pruritus in Alagille Syndrome, a rare liver disease, based on ASSERT Phase III trial data showing significant itch reduction and improved sleep.

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.

Kayfanda® (odevixibat) approved for treating cholestatic pruritus in children with Alagille Syndrome, based on ASSERT Phase III trial data showing significant itch reduction and improved sleep. Kayfanda is a non-systemic IBAT inhibitor, expanding Ipsen's rare cholestatic liver disease portfolio.