Calliditas partner STADA receives European Commission decision for full approval of Kinpeygo® for the treatment of IgA Nephropathy

Core Points - The European Commission has granted full marketing authorization for Kinpeygo, a treatment for adults with primary immunoglobulin A nephropathy (IgAN) [3] - This approval triggers a milestone payment of ten million EUR to Calliditas, which will be recognized as revenue in the third quarter [2] - Kinpeygo's status as an orphan drug for a rare disease has been confirmed, providing 10-year market exclusivity until 2032 [4] Group 1 - The full marketing authorization covers EU member states, Iceland, Norway, and Liechtenstein [4] - Kinpeygo is the first fully approved medication for IgAN, representing a significant advancement for patients [5] - The expanded label for Kinpeygo allows for a broader patient population, changing the urine protein excretion limitation from > 1.5g/g to ≥ 0.8g/g [7] Group 2 - The approval is based on data from the Phase 3 NefIgArd clinical trial, which demonstrated high statistical significance in meeting its eGFR endpoint [5][7] - The results of the trial were published in The Lancet, highlighting the efficacy and safety of the treatment [6] - The approval is seen as a crucial development for the treatment landscape of IgAN in Europe [5]