Aurinia Pharmaceuticals said that the US Food & Drug Administration (FDA) has approved a label update for Lupkynis (Voclosporin) to include long-term data from the AURORA clinical programme.
Lupkynis is an oral medicine for adult patients with active lupus nephritis (LN). It has been approved by both the FDA and the European Commission.
In the US, the drug’s updated label no longer includes the disclaimer regarding its safety and efficacy beyond one year.
Lupkynis now incorporates three-year data from the AURORA 2 double-blind, placebo-controlled extension study.
The study evaluated the long-term safety and tolerability of the medicine in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, compared to MMF and low-dose glucocorticoids alone.
The trial focused on adults with active lupus nephritis who had completed the Phase 3 AURORA 1 clinical trial.
The Nasdaq-listed Aurinia Pharmaceuticals said that the revised label now incorporates findings from a post hoc analysis of data from the extension study.
In AURORA 1, Lupkynis was administered in 179 patients while placebo was given to 178 patients.
According to the results, 20.1% of patients receiving Lupkynis and 11.8% of patients receiving placebo achieved sustained complete renal response (SCRR).
The label also shows that 21.8% of patients on Lupkynis and 23% in the placebo group had missing data either by the end of the first year or the two-year extension study, resulting in an unknown status for sustained complete renal response.
Additionally, the updated label introduces new recommendations for monitoring kidney function in patients undergoing Lupkynis treatment.
The label now advises physicians to evaluate the estimated glomerular filtration rate (eGFR) every two weeks during the initial month of therapy, every four weeks throughout the first year, and quarterly thereafter.
The safety profile of the drug in the revised label is consistent with the safety findings of the AURORA clinical programme and does not change.
Additional lactation information about the transfer of Lupkynis to breast milk based on a twice-daily dosage schedule is also included in the amended label.
Aurinia Pharmaceuticals chief medical officer Greg Keenan said: “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.”
