Ipsen's Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade [Yahoo! Finance]
GENFIT S.A. - American Depositary Shares (GNFT)
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Source: Yahoo! Finance
Approval 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 exerts an effect on the proteins PPARa and PPARd, thought to be key regulators of bile acid, inflammation and fibrosis. “We are delighted that Iqirvo is approved in the E.U.
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