Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases CHMP positive...
Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), July 26, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the...
US FDA grants accelerated approval to Genfit and Ipsen`s liver disease drug
Iqirvo® (elafibranor) 80 mg tablets is the first new medicine approved in nearly a decade for the treatment of the rare liver...
New data from the ELATIVE® Phase III trial show 70% of patients treated with elafibranor achieved composite endpoint of slowing disease progression measured by biochemical response after 78-weeksData...
US Food and Drug Administration (FDA) has granted Priority Review for New Drug Application (NDA) for elafibranor in PBC, and European Medicine Agency (EMA) has also validated the Marketing...
New Drug Application granted priority review with PDUFA date set for June 10, 2024European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor...
ELATIVE® Phase III trial confirms potential for investigational elafibranor as a novel, first-in-class, dual PPAR α,δ agonist for patients with primary biliary cholangitis.Elafibranor demonstrates...
PARIS, FRANCE, 30 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced positive topline data from the pivotal ELATIVE Phase III trial. In the trial the efficacy and safety of elafibranor, an investigational dual ?,? PPAR agonist, is being assessed for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA).
Trial met primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to placeboElafibranor was well tolerated with...