Aurinia Pharmaceuticals Inc. got its first drug approval with the FDA’s nod to Lupkynis (voclosporin) for treating active lupus nephritis in adults. It’s the first FDA-approved oral therapy for the indication and the second approval in little more than a month for those patients, following the agency’s Dec. 17 approval of Glaxosmithkline plc’s Benlysta (belimumab), for treating active LN.
New updates from a dynamic late-phase systemic lupus erythematosus pipeline shared at this week's American College of Rheumatology annual meeting and beyond showed a robust field of potential new treatments nearing the finish line.
Aurinia Pharmaceuticals Inc. is suspending further development of voclosporin ophthalmic solution (VOS) for dry eye syndrome after a dose-ranging trial of the candidate failed to meet its primary endpoint of improving a measure of the condition after four weeks of treatment.
In the summer of 2016, when Victoria, British Columbia-based Aurinia Pharmaceuticals Inc. offered phase IIb results with its calcineurin inhibitor voclosporin in lupus nephritis (LN), Wall Street ignored the otherwise-positive results and zeroed in on the trial’s death rate: 13 casualties across three arms of the 265-subject Aura-LV study.