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FDA Approves Updated LUPKYNIS (voclosporin) Label To Include Long-Term Data From The AURORA Clinical Program

Author: Benzinga Newsdesk | April 30, 2024 06:13am

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.

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