FDA Approves Updated LUPKYNIS (voclosporin) Label To Include Long-Term Data From The AURORA Clinical Program
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The FDA has approved an updated label for LUPKYNIS (voclosporin), removing the previous one-year limitation and now including three-year data from the AURORA 2 study. This study showcased the long-term safety and efficacy of LUPKYNIS in treating lupus nephritis in combination with other treatments.
April 30, 2024 | 10:13 am
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The FDA's approval of the updated LUPKYNIS label, including positive three-year data, is a significant endorsement of the drug's long-term efficacy and safety for lupus nephritis treatment.
The FDA's approval of the updated label for LUPKYNIS, which includes three-year data demonstrating its safety and efficacy, is likely to enhance the drug's market position and potentially increase its adoption among healthcare providers for treating lupus nephritis. This regulatory milestone directly impacts Aurinia Pharmaceuticals Inc. (AUPH), the company behind LUPKYNIS, by potentially boosting its stock price in the short term due to increased investor confidence in the drug's long-term market potential.
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