CymaBay Therapeutics Submits New Drug Application To FDA For Seladelpar

(RTTNews) - CymaBay Therapeutics, Inc. (CBAY) on Friday announced that it has submitted a New Drug Application (NDA) to the FDA for seladelpar, an investigational treatment for primary biliary cholangitis (PBC) in adults who are inadequate responders or intolerant to ursodeoxycholic acid (UDCA).

Seladelpar has been granted Breakthrough Therapy Designation by the FDA and is the only orally active PPARd agonist with Phase 3 trial results showing improvement in markers of cholestasis and pruritus.

CymaBay has requested a Priority Review of the NDA, which if accepted, would mean the FDA would plan to complete its review within six months of accepting the application.

CymaBay also intends to file marketing authorization applications to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) in the first half of 2024.