Posted by Michael Wonder on 15 Dec 2023
CymaBay submits new drug application to FDA for seladelpar for the treatment of primary biliary cholangitis
15 December 2023 - New drug application is supported by data evaluating seladelpar efficacy and safety in over 500 patients.
CymaBay Therapeutics today announced it has submitted a new drug application to the US 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.
