CymaBay submits NDA to FDA for seladelpar

CymaBay Therapeutics announced it has submitted a New Drug Application to the U.S. FDA for investigational treatment, seladelpar, for the management of primary biliary cholangitis, including pruritus in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid. 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. CymaBay intends to file marketing authorization applications to the European Medicines Agency and U.K. Medicines and Healthcare products Regulatory Agency in the first half of 2024. Seladelpar has received Priority Medicines status from the EMA, as part of the program to optimize development plans and speed up evaluation of priority medicines so they can reach patients earlier.