Calliditas Therapeutics.
Calliditas Therapeutics has announced that it has received full marketing authorisation from the European Commission regarding the biopharma company’s Kinpeygo treatment for adults with primary immunoglobulin A nephropathy (IgAN). This allows for a broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population, defined as UPCR of ≥ 0.8g/g, or proteinuria of ≥1.0 g/g over 24 hours.
This expansion is based on a two-year data set from the Phase 3 NeflgArd clinical trial, published in The Lancet. Kinpeygo is marketed exclusively in the UK and European Union (EU) by STADA Arzneimittel AG. The full authorisation covers the EU member states, Iceland, Norway and Liechtenstein. Additionally, the Commission also confirmed Kinpeygo’s status as an orphan drug for rare diseases until 2032.
“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.”