18 April 2019 - FDA grants elafibranor breakthrough therapy designation, based on Phase 2 data, for treatment of primary biliary cholangitis in adults with inadequate response to UDCA.

Genfit today announced that its lead product candidate elafibranor was granted breakthrough therapy designation by the U.S. FDA for the treatment of primary biliary cholangitis in adults with inadequate response to ursodeoxycholic acid (UDCA). 

Elafibranor is a first-in-class double peroxisome proliferator-activated receptor alpha and delta (PPAR alpha/delta) agonist which has produced positive results in a Phase 2 clinical trial evaluating its safety and efficacy in adults with PBC and inadequate response to UDCA. Elafibranor is also currently evaluated in a Phase 3 clinical trial in non-alcoholic steatohepatitis.

Read Genfit press release