Calliditas Seeks Full Approval for Kinpeygo in IgA Nephropathy

Calliditas Therapeutics AB, in collaboration with partner STADA Arzneimittel AG, has taken a significant step towards expanding patient access to Kinpeygo®, a treatment for primary IgA nephropathy (IgAN). STADA has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to convert the conditional marketing authorization for Kinpeygo to full marketing authorization.

Kinpeygo, an orphan medicinal product, is currently the only approved treatment for IgAN in the UK. IgAN is a rare autoimmune disease of the kidney with a high unmet need. The conditional approval allows Kinpeygo to be used to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression.

STADA, which holds the commercial rights in the European Economic Area (EEA) member states, Switzerland, and the UK, successfully launched Kinpeygo in Germany in September 2022. The company is now working towards extending patient access to other countries.

The submission for full approval to the MHRA is based on the comprehensive two-year data set from the Phase 3 NefIgArd clinical trial, recently published in The Lancet. The trial demonstrated that Kinpeygo provided a highly statistically significant benefit over placebo in estimated glomerular filtration rate (eGFR) over the two-year period.

This filing represents a significant milestone for Calliditas and STADA in their mission to address the unmet medical needs of patients with IgAN. By seeking full marketing authorization, they aim to ensure broader access to Kinpeygo, providing hope and improved treatment options for individuals suffering from this rare kidney disease.

For more information, please contact Åsa Hillsten, Head of Investor Relations & Sustainability at Calliditas.