STADA Arzneimittel (STADA) announced on Friday that it has taken a significant step towards expanding its Specialty portfolio after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorisation for KinpeygoTM.

The CHMP's positive opinion was for the use of Kinpeygo in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5g/gram.

If confirmed by the European Commission (EC), the company said that Kinpeygo will be the first and only treatment approved to treat 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). Under a licensing agreement with Calliditas Therapeutics announced in July 2021, Kinpeygo will be exclusively marketed by STADA in European Economic Area (EEA) member states, Switzerland and the UK.

STADA CEO Peter Goldschmidt commented, 'By combining through this partnership Calliditas' drug-delivery expertise and clinical data with STADA's pan-European commercial and supply-chain expertise, we are optimistic of bringing a specialty therapeutic option to an under-served patient population with what would be STADA's first orphan medicine. We look forward to further serving Europe's nephrology community, including through the epoetin zeta biosimilar that we have marketed for well over a decade.'