EU Authorizes Calliditas’ Kinpeygo for Primary IgA Nephropathy

The European Commission granted a conditional marketing authorization to Calliditas Therapeutics’ Kinpeygo (budesonide) for the treatment of adult patients with primary immunoglobulin A (IgA) nephropathy, a chronic kidney disease.

Also known as Berger’s disease, IgA nephropathy occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues. The condition progresses over 10 to 20 years and can lead to end-stage renal disease.

The EU approval was based on positive data from a phase 3 study in which the drug reduced protein levels in the urine and improved kidney function.

Kinpeygo is the first medication approved in the EU for this disease. Stada is planning on launching the drug in Europe later this year.