Calliditas partner STADA gets EC OK for treatment of IgA Nephropathy

  Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).

The European Commission has granted a full marketing authorization of Kinpeygo®. The granting of the full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population, defined as UPCR of ≥ 0.8g/g, or proteinuria of ≥1.0 g/g over 24 hours. This expanded label is based on full two-year data set from the Phase 3 NefIgArd clinical trial, published in leading medical journal The Lancet.

https://www.prnewswire.co.uk/news-releases/calliditas-partner-stada-receives-european-commission-decision-for-full-approval-of-kinpeygo-for-the-treatment-of-iga-nephropathy-302207686.html