Posted by Michael Wonder on 05 Oct 2023
Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy
3 October 2023 - Calliditas Therapeutics today announced that its partner STADA Arzneimittel has submitted a request to the MHRA of the United Kingdom to convert the conditional marketing authorisation for Kinpeygo, a treatment for primary IgA nephropathy, to standard, or "full", marketing authorisation.
The submission to the MHRA for full approval, made by STADA's affiliate Britannia Pharmaceuticals, is based on the full two year data set from the Phase 3 NefIgArd clinical trial, as recently published in The Lancet.
