Aurinia Pharmaceuticals: FDA approves updated LUPKYNIS label

Aurinia Pharmaceuticals 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 and low-dose glucocorticoids, compared with MMF and low-dose glucocorticoids alone, in adults with active lupus nephritis who completed the Phase 3 AURORA 1 clinical trial.