Stada and Calliditas Have Collaboratively Announced the Submission of an Extensive Application for Complete Marketing Approval of Kinpeygo® Within the European Union

Friday, September 29, 2023

STADA and Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) have jointly announced their application submission to the European Medicines Agency (EMA) for the conversion of the conditional marketing authorization of Kinpeygo® to standard or "full" marketing authorization. Kinpeygo® is a treatment designed for primary IgA nephropathy (IgAN).

Presently, Kinpeygo® holds conditional approval for the reduction of proteinuria in adults with primary IgAN who are at risk of rapid disease progression, specifically those with a urine protein-to-creatinine ratio (UPCR) of ≥1.5 g/gram. This conditional approval was granted in the interest of public health due to its addressing of an unmet medical need, with the immediate benefits deemed to outweigh the risk associated with having less comprehensive data than what is typically required.

Kinpeygo® is the first and only approved treatment for IgAN in Europe, which is a rare autoimmune kidney disease characterized by significant unmet medical needs. STADA, holding European commercial rights, initiated the launch of Kinpeygo® in Germany in September 2022 and is actively working to expand patient access to other European countries.

The application for full approval submitted to CHMP is supported by comprehensive two-year data from the Phase 3 NefIgArd clinical trial, recently published in The Lancet[1]. This double-blind, multicenter study evaluated the efficacy and safety of Kinpeygo® (developed under the project name Nefecon®) administered at a daily dose of 16 mg, in comparison to a placebo, alongside optimized renin-angiotensin system inhibitor (RASi) therapy in adult patients with primary IgAN. The trial successfully achieved its primary endpoint, with Kinpeygo® demonstrating a highly statistically significant benefit over the placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period. This period included 9 months of treatment with Kinpeygo® or placebo and 15 months of follow-up after discontinuation of the drug.

Bryan Kim, STADA's Head of Global Specialty, expressed optimism, stating, "By seeking standard marketing authorization from the EMA, based on the full dataset as published in The Lancet journal, STADA and Calliditas are hopeful about expanding access to this vital specialty therapy for individuals with IgAN across Europe."

Renée Aguiar-Lucander, Chief Executive Officer of Calliditas Therapeutics, highlighted the potential of the treatment, saying, "The eGFR treatment benefit observed across the entire study population, regardless of UPCR levels, provides further evidence that targeting IgAN at its source can offer patients a treatment with the potential for disease modification. We are pleased to provide the EMA with the full results of our Phase 3 study and look forward to engaging with the regulatory agency regarding the full approval of Kinpeygo."



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