European Commission approves Kinpeygo for adults with primary IgA nephropathy.- Calliditas Therapeutics AB + Stada Arzneimittel AG.
Calliditas Therapeutics AB announced that the European Commission (EC) has granted conditional marketing authorization for Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) greater than 1.5 g/gram.
Kinpeygo is an orphan medicinal product and the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).
Kinpeygo will be marketed in the European Economic Area (EEA) exclusively by STADA Arzneimittel AG.
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