CSL Vifor and Travere's sparsentan CMA accepted by EMA

CSL Vifor and Travere Therapeutics (Nasdaq: TVTX) today announced that the European Medicines Agency (EMA) has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare kidney disorder and a leading cause of end-stage kidney disease (ESKD).

The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.

“The acceptance of the EU regulatory application for sparsentan marks a major milestone towards our goal of bringing this first-in-class therapy to the patients suffering from IgAN, for which there are currently no approved non-immunosuppresive therapies,” ccommented Klaus Henning Jensen, chief medical officer of CSL Vifor, now part of Australia’s CSL Limited (ASX: CSL). “We look forward to working closely with our partner, Travere, through the EMA review process with the aim to bring this innovative treatment option to patients living with IgAN in Europe,” he noted.