Gilead Becomes Third To Market In Second-Line PBC, With Label Advantages

Gilead Sciences, Inc. made a substantial bet on moving into a different kind of liver disease with its $4.3bn takeout in February of CymaBay Therapeutics, Inc., and that transaction is beginning to bear fruit with the US Food and Drug Administration approval on 14 August of Livdelzi (seladelpar) for second-line treatment of primary biliary cholangitis (PBC). In that setting, Livdelzi will compete against two second-line agents, Alfasigma S.p.A.’s Ocaliva (obeticholic acid), approved in 2016, and Ipsen SA/Genfit SA’s Iqirvo (elafibranor), which obtained FDA approval in June.

In an interview with Scrip, Gilead executive director of global medical affairs for liver diseases Carrie Frenette declined to offer specifics about how the company will position Livdelzi against Ocaliva, an FXR agonist, or Iqirvo, which like Livdelzi is a PPAR agonist. Iqirvo targets both the alpha and delta peroxisome proliferator-activated receptors, while Gilead’s drug only addresses the delta receptor