Posted by Michael Wonder on 29 Sep 2023
STADA and Calliditas announce the filing for full marketing authorisation of Kinpeygo in the EU
28 September 2023 - Submission to the CHMP for full approval is based on the full two-year data set from the Phase 3 NefIgArd clinical trial, as recently published in leading medical journal The Lancet.
Partners STADA and Calliditas Therapeutics today announced the submission of a request to the EMA for the CHMP to convert the conditional marketing authorisation for Kinpeygo, their treatment for primary IgA nephropathy, to standard, or "full", marketing authorization.
