Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
Kinpeygo is the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD). The MHRA authorization follows the European Commission (EC) authorization in July of 2022. Calliditas will transfer the CMA to its partner STADA Arzneimittel AG, which is commercializing Kinpeygo in the European Economic Area (EEA) member states, Switzerland and the UK. STADA launched Kinpeygo in its lead launch market, Germany, in October 2022.
“We are happy to be able to add another approval in a European territory, which will lead to patient access to Kinpeygo, a drug developed specifically to target this disease,” said CEO Renée Aguiar-Lucander.
