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Calliditas Therapeutics AB has announced that its partner STADA Arzneimittel AG has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorisation for Kinpeygo a treatment for primary IgA nephropathy (IgAN), to standard, or “full”, marketing authorisation.
Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need. Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. STADA, which holds the commercial rights in the European Economic Area (EEA) member states, Switzerland and the UK, has already launched the IgAN medicine in Germany in September 2022 and is working to extend patient access to other countries.
The submission to the MHRA for full approval, made by STADA’s affiliate Britannia Pharmaceuticals Ltd., 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. The trial met its primary endpoint, with Kinpeygo demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of nine months of treatment with Kinpeygo or placebo and 15 months of follow-up off drug.