Voclosporin Found to be Effective in Both Hispanic/Latino and non-Hispanic/Latino Populations with Lupus Nephritis
In a new study of voclosporin, researchers further validated its safety and efficacy. Notably, the study found that the 1-year renal (kidney) response for Hispanic patients, a population at higher risk for lupus nephritis (lupus-related kidney disease), was 37.9% compared to just 19.4% of those in the control group.
In July, the Food and Drug Administration (FDA) accepted Aurinia’s filing of its new drug application (NDA) for voclosporin. At the filing date, the FDA has six months to determine whether it will approve voclosporin as a new treatment for lupus nephritis.
Inside Lupus Research will continue to share updates and next steps.
In a Phase 3 trial, investigational drug voclosporin achieved its primary and secondary treatment goals in both Hispanic/Latino and non-Hispanic/Latino study participants with lupus nephritis (LN), outperforming the control group across every assessed measure of kidney function. The drug was well tolerated with no unexpected safety concerns.
The study findings affirm those demonstrated in the previously completed Phase 2b AURA-LV trial. There were 357 people with active LN enrolled in the study; 88% were female and 33% were of Hispanic/Latino ethnicity. After 52 weeks of treatment, 38.6% of people in the Hispanic/Latino group receiving voclosporin achieved renal (kidney) response, compared to just 18.6% of those in the control group. The non-Hispanic/Latino participants treated with voclosporin also benefited from improved renal response compared to the control group (41.8% versus 24.6%, respectively).
"Lupus nephritis standard of care treatment currently has about a 50/50 chance of showing some disease improvement, terrible odds given the potential for kidney failure and mortality. There are currently no therapies that are FDA approved for treating lupus nephritis, therefore this study is a major step forward in the care of our patients,” said Cristina Arriens, M.D., study author.
LN can develop into life-threatening kidney failure, and new treatment options are essential for improving disease outcomes and quality of life for people living with the disease. These latest results are especially encouraging, as the Hispanic/Latino LN population is especially difficult to treat. Continue to follow the Lupus Foundation of America for updates on voclosporin and read frequently asked questions about the drug.