FDA approves updated Lupkynis (voclosporin) label to include long term data from the Aurora Clinical Program.-- Aurinia Pharmaceuticals.
Aurinia Pharmaceuticals Inc. 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 III 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 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.
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 III, 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.(previously cited).
AURORA 2 (referred to in label as Study 1 extension ), a Phase III, 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 (previously cited).
Patients who completed 12 months of treatment in the Phase III 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.
A total of 216 LN patients continued into the extension study, with 116 patients in the voclosporin group and 100 patients in the control group; 90 and 78 patients, respectively, received 36 months of total treatment at the completion of the study. Study drug dose changes decreased over time.
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