European Commission grants full approval of Kinpeygo (budesonide enteric formulation) for the treatment of IgA nephropathy

The European Commission has granted a full marketing authorization of Kinpeygo. 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 greater than 1.5g/g to encompassing the entire study population, defined as UPCR of greater than 0.8g/g, or proteinuria of greater than 1.0 g/g over 24 hours. This expanded label is based on full two-year data set from the Phase III 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” said Renee Aguiar-Lucander, CEO.

Kinpeygo is marketed in in the EU and UK exclusively by Calliditas’ commercial partner, STADA Arzneimittel AG.

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.

See- "Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy"- (NefIgArd): 2-year results from a randomized phase III trial .The Lancet Vol. 402 No. 10405 p859–870. Published: August 14, 2023 - Richard Lafayette, Jens Kristensen, Andrew Stone, Jürgen Floege, Vladimir Tesa?, Hernán Trimarchi and others– The Lancet.