The treatment was developed by Calliditas and will be marketed by Stada

The European Commission (EC) has granted conditional marketing authorisation for Kinpeygo (budesonide) capsules for the treatment of primary immunoglobulin A nephropathy (IgAN).

The treatment involves adults at risk of rapid disease progression with a specific urine protein-to-creatinine ratio.

Kinpeygo is an orphan medicinal product and the first and only approved treatment for IgAN – a rare, progressive autoimmune disease of the kidney, with more than 50% of patients potentially progressing to end-stage renal disease. Through a partnership with developer Calliditas Therapeutics, Kinpeygo will be marketed in the European Economic Area (EEA) exclusively by Stada.

The conditional marketing authorisation applies in all 27 European Union member states, as well as Iceland, Norway and Liechtenstein. Stada intends to initiate launches in European markets during the second half of 2022.

Stada chief executive officer Peter Goldschmidt reflected: “Approval of Kinpeygo is a crucial milestone in STADA bringing a therapeutic option to an under-served patient population across Europe. The impending launch of STADA’s first orphan Specialty medicine is testament to the growing breadth of our portfolio.”

The Kinpeygo approval is based on the efficacy and safety data of Part A of the NeflgArd pivotal phase 3 study, which is an ongoing, randomised, double-blind, placebo-controlled, multicentre study conducted to evaluate Kinpeygo. The study focused on a once daily oral dose versus placebo in adult patients with primary IgAN.

Stada is headquartered in Bad Vilbel, Germany – the company has a three-pillar strategy consisting of generics, specialty pharma and consumer healthcare products. Worldwide, it sells its products in approximately 120 countries and employs 12,520 people worldwide.