Calliditas Therapeutics AB announced the European Commission gave conditional marketing authorization for Kinpeygo.
According to a press release, the conditional marketing authorization applies in all member states of the EU, as well as Iceland, Norway and Liechtenstein.
Kinpeygo is designed to treat primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression and who have a urine protein to creatinine ratio of at least 1.5g/gram. The treatment was developed under the name Nefecon.
The European Commission approval follows part A of the NeflgArd pivotal phase 3