Calliditas Therapeutics and STADA receive full EU approval for Kinpeygo® to treat primary IgA Nephropathy, based on Phase 3 NefIgArd trial data.
Calliditas Therapeutics and partner STADA receive full EU approval for Kinpeygo®, used to treat adults with primary IgA Nephropathy. The approval expands the label, moving from a UPCR limitation of >1.5g/g to encompassing the entire study population, defined as UPCR ≥ 0.8g/g or proteinuria ≥ 1.0 g/g over 24 hours. This decision is based on full two-year data from the Phase 3 NefIgArd clinical trial.
July 26, 2024
4 Articles