AUPH - Aurinia's voclosporin integrated data shows benefit in kidney inflammation
Aurinia Pharmaceuticals (AUPH) has announced that integrated efficacy and pharmacokinetic data from AURA-LV and AURORA pivotal trials of voclosporin in lupus nephritis ((LN)) were presented at the American Society of Nephrology Kidney Week.Integrated data from 534 patients from both the trials demonstrated that 268 patients with LN treated with voclosporin in combination with mycophenolate mofetil ((MMF)) and low-dose steroids achieved statistically superior and faster Renal Response rates compared to 266 patients treated with MMF and steroids alone.Renal Response rate of 43.7% was achieved with voclosporin compared to 23.3% in the control arm at one year and at six months (voclosporin 31.7%; placebo 20.3%).Voclosporin was shown to inhibit calcineurin in a dose-dependent manner, thus potentially eliminating the need for therapeutic drug monitoringThe data presented was submitted as part of voclosporin’s marketing application filed to the FDA.
For further details see:
Aurinia's voclosporin integrated data shows benefit in kidney inflammation