Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade
IPSEN SA S/ADR (IPSEY)
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Source: GlobeNewswire
European Commission grants conditional marketing authorization for Iqirvo® (elafibranor), first-in-class new treatment for primary biliary cholangitis (PBC), a rare liver diseaseApproval follows positive CHMP opinion based on ELATIVE phase III trial data, which demonstrated significant efficacy over placebo and was well-tolerated with an acceptable safety profile This new European approval reinforces Ipsen’s commitment to advancing medical innovations to treat people living with rare cholestatic liver diseases PARIS, FRANCE, 20 September 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the European Commission has conditionally approved Iqirvo® (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist, that ex
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News
- Bylvay® (odevixibat) data shows sustained improvement in severe itch and serum bile acid levels in patients with PFIC and ALGSGlobeNewswire
- Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritusGlobeNewswire
- Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidanceGlobeNewswire
- Ipsen’s Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver diseaseGlobeNewswire
- Ipsen S.A. (OTCMKTS: IPSEY) was upgraded by analysts at Royal Bank of Canada from a "hold" rating to a "moderate buy" rating.MarketBeat