Kinpeygo, which was granted conditional marketing authorisation in EU on 15 July 2022, was the first ever approved treatment for IgAN in the EU and UK. The full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population, defined as UPCR of ≥ 0.
8g/g, or proteinuria of ≥1.0 g/g over 24 hours. Kinpeygo is marketed in in the EU and UK exclusively by Calliditas' commercial partner, STADA Arzneimittel AG.
"This is an important day for patients suffering from IgAN in Europe as Kinpeygo represents the first ever fully approved medication for this rare kidney disease. The long-term confirmatory trial met its eGFR endpoint with high statistical significance and we are delighted that EMA now has issued a positive opinion," said Renee Aguiar-Lucander, CEO. The CHMP's positive opinion will now be forwarded to the European Commission (EC), which has the authority to grant this full marketing authorisation for Kinpeygo in the European Union (EU) member states, and which will be adopted by Iceland, Norway and Liechtenstein.
A final decision by the EC on granting a marketing authorisation is anticipated in August 2024. For further information, please contact : Åsa Hillsten, Head of IR & Sustainability, Calliditas Tel.: +46 76 403 35 43, Email: [email protected] The information in the report is information that Calliditas is obliged to make public pursuan.
