BRIEF—EMA accepts MAA for seladelpar for the treatment of primary biliary cholangitis

US pharma company CymaBay Therapeutics today announced that the Marketing Authorization Application (MAA) for seladelpar, for the treatment of primary biliary cholangitis (PBC), has been validated and will be reviewed by the European Medicines Agency (EMA).

Seladelpar received Priority Medicines (PRIME) status from the EMA in 2016, as part of its program to enhance support for the development of medicines that target an unmet medical need.

Also, the US Food and Drug Administration accepted the New Drug Application for seladelpar, with a PDUFA date of August 14, 2024.

Klara Dickinson, chief regulatory and compliance officer at CymaBay Therapeutics, said: “Validation of the European Marketing Authorization Application for seladelpar and the start of the agency’s formal review is an important step forward in seladelpar’s journey to potential approval in Europe. We look forward to further discussion with the agency and rapporteurs as they conduct their review.”