Calliditas Therapeutics announced that its partner Stada Arzneimittel has submitted a request to the Medicines and Healthcare products Regulatory Agency, or MHRA, of the United Kingdom to convert the conditional marketing authorization, or CMA, for Kinpeygo, a treatment for primary IgA nephropathy, or IgAN, to standard, or “full”, marketing authorization. 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 leading medical journal The Lancet. The trial met its primary endpoint, with Kinpeygo demonstrating a highly statistically significant benefit over placebo in estimated glomerular filtration rate over the two-year period of nine months of treatment with Kinpeygo or placebo and 15 months of follow-up off drug.
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