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

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the FDA has approved a label update for LUPKYNIS. The updated label no longer includes language indicating that the safety and efficacy of LUPKYNIS has not been established beyond one year. The label now includes three-year data from the AURORA 2 double-blind, placebo-controlled extension study, which assessed the long-term safety and tolerability of LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, compared with MMF and low-dose glucocorticoids alone, in adults with active lupus nephritis (LN) who completed the Phase 3 AURORA 1 clinical trial.

A post hoc analysis of data from the extension study now included in the label showed that, among the 179 patients receiving LUPKYNIS and 178 patients receiving placebo in AURORA 1, 20.1% (n=36) and 11.8% (n=21) achieved sustained complete renal response (SCRR), respectively. SCRR was defined as achieving renal response at month 12 of AURORA 1 and maintaining renal response at subsequent clinic visits through the end of the extension study at month 36. The label also notes that 21.8% (n = 39) of patients receiving LUPKYNIS, and 23% (n = 41) in the placebo arm, had missing data at the end of the first year or by the end of the two-year extension study, and therefore have an unknown status for sustained complete renal response.

The updated label also provides new guidance for monitoring kidney function in patients taking LUPKYNIS. The label indicates that physicians should assess eGFR every two weeks for the first month of treatment, every four weeks through the first year, and quarterly thereafter. The label had previously stated that eGFR should be assessed every four weeks for the duration of treatment. The updated LUPKYNIS label supports quarterly monitoring of eGFR after the first year of treatment, which is more consistent with current standard clinical care.

“Data from our AURORA 2 extension study included in the LUPKYNIS label showed a maintenance of sustained complete renal response with LUPKYNIS in combination with MMF and low-dose glucocorticoids, at every time point assessed through three years, relative to MMF and low-dose glucocorticoids alone. This notable outcome is aligned with treatment guidelines calling for use of LUPKYNIS for at least three years to reduce proteinuria. Additionally, guidance on monitoring kidney function quarterly after the first year of LUPKYNIS treatment reflects the reality of clinical practice. Overall, this label update provides physicians with important information to treat and manage their LN patients,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.