Calliditas Therapeutics Makes History, Full Marketing Authorization Granted By European Commission

 Calliditas Therapeutics has received full marketing authorization from the European Commission for its Kinpeygo treatment aimed at adults with primary immunoglobulin A nephropathy (IgAN). This approval broadens the treatment’s label, allowing it to include a wider range of patients with primary IgAN by changing the urine protein excretion (UPCR) criteria from > 1.5 g/g to a more inclusive UPCR of ≥ 0.8 g/g or proteinuria of ≥ 1.0 g/g over a 24-hour period.

This decision is supported by a comprehensive two-year data set from the Phase 3 NeflgArd clinical trial, which was published in The Lancet. Kinpeygo is exclusively marketed in the UK and the European Union (EU) by STADA Arzneimittel AG, and the authorization extends to all EU member states, as well as Iceland, Norway, and Liechtenstein. Furthermore, the European Commission has reaffirmed Kinpeygo’s designation as an orphan drug for rare diseases, valid until 2032.

Renee Aguiar-Lycander, CEO, said that “This is an important event for patients suffering from IgAN in Europe as Kinpeygo represents the first ever fully approved medication for this rare kidney disease,” said Renee Aguiar-Lycander, CEO. The long-term confirmatory trial met its eGFR endpoint with high statistical significance and we are delighted that the European Commission has granted a full approval for the broader population.”