FDA Updates LUPKYNIS® Label with Three-Year Data and Modified Kidney Function Monitoring Guidelines for Lupus Nephritis
核心洞察
The FDA has updated the label for LUPKYNIS® (voclosporin) to include three-year data from the AURORA 2 extension study, demonstrating sustained complete renal response in patients with lupus nephritis (搜索) (LN).
The updated label provides new guidance for monitoring kidney function, recommending quarterly eGFR assessments after the first year of treatment, aligning with standard clinical care.
The safety profile of LUPKYNIS® remains consistent with previous findings from the AURORA clinical program, with no new safety concerns identified in the long-term data.
Aurinia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for LUPKYNIS® (voclosporin), incorporating three-year data from the AURORA 2 extension study and modifying guidelines for kidney function monitoring in adult patients with active lupus nephritis (搜索) (LN). The updated label now includes long-term data demonstrating sustained complete renal response (SCRR) with LUPKYNIS, in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, compared to MMF and low-dose glucocorticoids alone.
Sustained Renal Response Data
The updated label includes a post hoc analysis of the AURORA 2 extension study data, revealing that 20.1% (n=36) of patients receiving LUPKYNIS achieved SCRR compared to 11.8% (n=21) of patients receiving placebo. SCRR was defined as achieving renal response at month 12 of the AURORA 1 study and maintaining it through month 36 in the extension study. The label also notes that a portion of patients in both arms had missing data, impacting the assessment of SCRR.
Modified Kidney Function Monitoring
The updated label refines the guidance for monitoring kidney function, recommending eGFR assessments every two weeks for the first month, every four weeks through the first year, and quarterly thereafter. This change aligns with current clinical practice, reducing the frequency of monitoring after the initial treatment period.
Clinical Perspective
"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," said Dr. Greg Keenan, Chief Medical Officer of Aurinia. "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."
Safety Profile
The safety profile of LUPKYNIS remains consistent with the AURORA Clinical Program findings. The updated label also includes additional lactation data regarding the transfer of LUPKYNIS to breast milk, providing valuable information for lactating women and their healthcare providers.
About the AURORA Program
The AURORA program included the AURORA 1 pivotal trial and the AURORA 2 extension study. AURORA 1 demonstrated the clinical superiority of voclosporin in achieving complete renal response (CRR) in patients with LN when combined with MMF and low-dose glucocorticoids, compared to MMF and low-dose glucocorticoids alone. The AURORA 2 extension study assessed the long-term safety and tolerability of voclosporin, showing maintained clinical efficacy over three years, as evidenced by reductions in urine protein creatinine ratio, sustained complete renal response, and preserved kidney function.