Calliditas Therapeutics has announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).
The granting of the full approval results in a significantly 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, states the company. This expanded label is based on full two-year data set from the Phase 3 NefIgArd clinical trial, published in leading medical journal The Lancet.
“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. 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,” says Renee Aguiar-Lucander, CEO.
This approval triggers a milestone payment of EUR 10 million to Calliditas, which will be recognized as revenue in the third quarter.
Kinpeygo is marketed in in the EU and UK exclusively by Calliditas’ commercial partner, STADA Arzneimittel. The full marketing authorization for Kinpeygo covers the European Union (EU) member states as well as Iceland, Norway and Liechtenstein. Also, Kinpeygo’s status as an orphan drug for a rare disease, subject to 10-year market exclusivity running until 2032, was confirmed by the Commission.
This approval triggers a milestone payment of EUR 10 million to Calliditas, which will be recognized as revenue in the third quarter.
Photo of Renee Aguiar-Lucander: Calliditas
