Posted by Michael Wonder on 23 Oct 2023
Seladelpar granted revised breakthrough therapy designation for the treatment of primary biliary cholangitis including pruritus in patients without cirrhosis or with compensated cirrhosis
23 October 2023 - CymaBay Therapeutics today announced that the US FDA has revised the originally granted breakthrough therapy designation for seladelpar to now reflect treatment of primary biliary cholangitis including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A).
Seladelpar is the only potent, selective, orally active PPARδ agonist, or delpar, with Phase 3 results demonstrating a statistically significant improvement in primary biliary cholangitis related cholestatic pruritus.
