Recently, CymaBay Therapeutics announced it has submitted a New Drug Application (NDA) to the FDA for investigational treatment, seladelpar, for the management of primary biliary cholangitis, including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid (UDCA). CymaBay has requested a Priority Review of the NDA that, if accepted, would mean the FDA would plan to complete its review within six months of accepting the application. Seladelpar has been granted Breakthrough Therapy Designation by the FDA and is the only potent, selective, orally active delpar, or PPARδ agonist, with Phase 3 trial results demonstrating a statistically significant improvement in markers of cholestasis related to risk of progression and PBC-related pruritus.
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