Calliditas Therapeutics AB (CALT) said the CHMP of the European Medicines Agency adopted a positive opinion recommending the granting of a conditional marketing authorisation for Kinpeygo for the treatment of primary immunoglobulin A nephropathy in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio =1.5 g/gram. A final decision by the European Commission on granting a marketing authorisation is anticipated in third quarter of 2022.
The company noted that, upon approval Kinpeygo, which was developed under the name Nefecon, will be marketed exclusively by STADA Arzneimittel AG.
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