CymaBay announces European Medicine accepts for review the MAA for seladelpar

CymaBay Therapeutics announced that the Marketing Authorization Application, MAA, for seladelpar, for the treatment of primary biliary cholangitis, PBC, including pruritus in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid, has been validated and will now be reviewed by the European Medicines Agency. Seladelpar is an investigational, potent, selective peroxisome proliferator-activated receptor delta agonist or delpar, in development for PBC treatment. The MAA application includes data from across the seladelpar PBC clinical development program in over 500 people with PBC, including from the pivotal, double blind, placebo-controlled, global Phase 3 RESPONSE study, recently published in the New England Journal of Medicine. The study’s primary endpoint measure reflects registrational studies of the current second line PBC treatment authorized by the EMA. In this study seladelpar demonstrated statistically significant improvements in biochemical markers of disease progression and PBC-related pruritus pre-specified endpoints. The number of adverse events was similar in the groups treated with seladelpar and placebo. The application is further supported by data from the Phase 3 ENHANCE study, the long-term open label ASSURE study, Phase 2 studies, pre-clinical studies and includes chemistry, manufacturing, and controls data. Under the European centralized licensing procedure, the EMA Committee for Medicinal Products for Human Use will review the application for all 27 Member States of the European Union, as well as Iceland, Liechtenstein and Norway.