Posted by Michael Wonder on 12 Feb 2024
CymaBay announces FDA acceptance of NDA and priority review for seladelpar for the treatment of primary biliary cholangitis
12 February 2024 - FDA has granted priority review with a target PDUFA date of 14 August 2024.
CymaBay Therapeutics today announced that the US FDA accepted its new drug application for seladelpar, an investigational treatment 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.
