CymaBay granted revised Breakthrough Therapy Designation for seladelpar

CymaBay Therapeutics announced that the U.S. Food and Drug Administration 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. Seladelpar is the only potent, selective, orally active PPARdelta agonist, or delpar, with phase 3 results demonstrating a statistically significant improvement in PBC-related cholestatic pruritus. The FDA’s original Breakthrough Therapy Designation for seladelpar was granted in 2019 and was based on preliminary results from a Phase 2 clinical trial, which showed that seladelpar was associated with a substantial reduction in serum alkaline phosphatase. The updated Breakthrough Therapy Designation of seladelpar was granted based on additional evidence provided to the Agency, which supports that seladelpar may provide substantial improvement over existing therapy based on a reduction in alkaline phosphatase and pruritus in patients without cirrhosis or with compensated cirrhosis.