AUPH - Aurinia presents additional data highlighting benefit of lupus nephritis therapy

Aurinia Pharmaceuticals (AUPH) has announced additional efficacy data from two pivotal trials for Lupkynis™ (voclosporin) in lupus nephritis (“LN”).Lupkynis was approved by the FDA in January as a combination therapy with a background immunosuppressive therapy regimen to treat adults with active LN.Data from AURA-LV and AURORA 1 studies involving 532 patients were integrated into a post-hoc analysis of complete renal response (“CRR”) by LN biopsy class. The odds ratios (“OR”) for CRR for Lupkynis versus placebo: 4.26 for pure Class III (p=0.0054), 2.59 for pure Class IV (p=0.0005), 1.5 for pure Class V (p=0.4090), and 2.68 for mixed Class III/IV and V patients (p=0.0166).OR of more than 1 indicates Lupkynis is favored over placebo. And Pure Class V was the least frequent in the study with only 75 patients in both studies.However, the studies were not powered to detect a statistical difference between the study arms by biopsy class, the company said.Aurinia estimates ~$65K

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Aurinia presents additional data highlighting benefit of lupus nephritis therapy