The U.S. Food & Drug Administration (FDA) Approves Updated LUPKYNIS (voclosporin) Label to include Long-Term Data from the AURORA Clinical Program - Seite 2

The safety profile of LUPKYNIS in the updated label remains unchanged and is aligned with the safety findings in the AURORA Clinical Program.

The updated label also provides additional lactation data on the transfer of LUPKYNIS to breast milk based on a twice daily dosing regimen. This information will be useful to lactating women and their health care providers who need to make informed decisions about breast feeding while taking LUPKYNIS.

About the AURORA Clinical Program

In AURORA 1 (referred to in label as Study 1), a 12-month, phase 3, double-blind, randomized-controlled pivotal study, the efficacy and safety of voclosporin was compared with a control group in achieving CRR in patients with LN. AURORA 1 demonstrated the clinical superiority of voclosporin with mycophenolate mofetil (MMF) and low-dose glucocorticoids compared to MMF and low-dose glucocorticoids alone. Significantly more patients in the voclosporin group achieved a CRR at 52 weeks of treatment and did so significantly faster than those in the control group. The safety profile in AURORA 1 was comparable between treatment groups, in line with previous studies; no new safety concerns were observed. Results from the completed Phase 3 randomized, double-blind, placebo-controlled, multicenter AURORA 1 study were published in The Lancet.

AURORA 2 (referred to in label as Study 1 extension), a Phase 3, double-blind, extension study assessed the long-term safety and tolerability of voclosporin, in addition to MMF and low-dose glucocorticoids, for the treatment of patients with active LN. Voclosporin was well tolerated with no new or worsening safety signals in the extension study. Clinical efficacy over three years of treatment was maintained, as observed by maintenance of urine protein creatinine ratio reductions, sustained complete renal response and preserved kidney function, suggesting a positive benefit-risk profile for voclosporin in LN patients. Full results of the extension study were published in Arthritis & Rheumatology, the official peer-reviewed journal of the American College of Rheumatology.

Patients who completed 12 months of treatment in the Phase 3 AURORA 1 study were eligible to enroll in the AURORA 2 extension study with the same randomized treatment of voclosporin or placebo, in combination with MMF (target dose of 2 g/day) and low-dose glucocorticoids (target dose of ≤2.5 mg/day), for an additional 24 months.