Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for KinpeygoTM for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
If confirmed by the European Commission (EC), Kinpeygo will be the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD). Upon approval Kinpeygo, which was developed under the name Nefecon, will be marketed exclusively by STADA Arzneimittel AG.
The CHMP’s positive opinion will now be forwarded to the EC, which has the authority to grant a marketing authorisation for Kinpeygo in the European Union (EU) member states, and which will be adopted by Iceland, Norway and Liechtenstein. A final decision by the EC on granting a marketing authorisation is anticipated in Q3 2022. Kinpeygo is already marketed under an accelerated approval in the United States under the brand name TARPEYOTM.
“This is a great outcome, which reflects the strong clinical results from our Phase 3 trial. We are delighted that patients suffering from IgAN in Europe will hopefully soon be able to access a drug developed specifically to target this disease.” said Calliditas Therapeutics CEO Renée Aguiar-Lucander.
In May 2021, Calliditas announced that it had submitted a Marketing Authorisation Application (MAA) to the EMA, which had previously granted Orphan Drug Designation to this drug candidate in the treatment of IgAN. In July 2021, Calliditas Therapeutics and STADA announced that the two companies had entered into a license agreement to register and commercialize Kinpeygo in the European Economic Area (EEA) member states, Switzerland and the UK.
If confirmed by the European Commission (EC), Kinpeygo will be granted a conditional marketing authorisation that is based on achievement of the primary endpoint of reduction of proteinuria in Part A of the NeflgArd pivotal Phase 3 study. Patients taking 16mg of Kinpeygo once daily showed a statistically significant 31% reduction in proteinuria from baseline vs 5% in the placebo arm after 9 months of treatment.