Posted by Michael Wonder on 25 Jul 2022
Aurinia announces positive CHMP opinion for Lupkynis (voclosporin) for the treatment of adults with active lupus nephritis in Europe
22 July 2022 - Positive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA efficacy study and the AURORA 2 continuation study, demonstrating voclosporin to be safe and well tolerated for up to three years of treatment.
Aurinia Pharmaceuticals today announced that the CHMP of the EMA adopted a positive opinion recommending voclosporin (Lupkynis) for marketing authorisation to treat adults with active lupus nephritis, a serious complication of systemic lupus erythematosus.
