Spherix Global Insights’ Post

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Partners STADA Group and Calliditas Therapeutics announce the European Commission full approval for Kinpeygo® for the treatment of adults with primary immunoglobulin A nephropathy (IgAN), making it the first fully approved disease-modifying treatment for IgAN in the EU.   This approval results in a broader label for patients with primary IgAN and is based on data from the Phase 3 NeflgArd clinical trial, where Kinpeygo met its eGFR endpoints with high statistical significance. Additionally, the EC confirmed Kinpeygo’s status as a rare disease orphan drug, which subjects it to 10-year market exclusivity until 2032.   Read More: https://lnkd.in/e78V5Hhg   #Nephrology #IgAN #Kinpeygo #STADA #Calliditas

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