Stada, Calliditas submit EMA request to convert Kinpeygo marketing authorization

Partners Stada and Calliditas Therapeutics announced the submission of a request to the European Medicines Agency, or EMA, for the Committee for Medicinal Products for Human Use, or CHMP, to convert the conditional marketing authorization for Kinpeygo, their treatment for primary IgA nephropathy, or IgAN, to standard, or “full”, marketing authorization. Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio of 1.5 g/gram. This was granted in the interest of public health because the medicine addresses an unmet medical need, and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required.