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Aurinia Completes Submission of New Drug Application to the U.S. Food & Drug Administration for Voclosporin for the Treatment of Lupus Nephritis
- Potential for voclosporin to become the first FDA-approved therapy for the treatment of lupus nephritis - - NDA Application supported by extensive global
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- Potential for voclosporin to become the first FDA-approved therapy for the treatment of lupus nephritis -\n\n\n- NDA Application supported by extensive global clinical program including the pivotal Phase 3 AURORA study and the pivotal Phase 2 AURA LV study - \n\n VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)--\n\nAurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced the completion of the rolling submission of a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) for voclosporin as a potential treatment for lupus nephritis (“LN”), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus (“SLE”). There are currently no FDA-approved treatments for LN. The NDA submission includes a request for Priority Review, which, if granted, would shorten the FDA’s review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months.\n\n\n“LN is a severe and debilitating consequence of lupus, which can severely impact the quality of life of individuals struggling with this disease. The Aurinia team continues to work incredibly hard towards delivering the first FDA‑approved treatment option for those affected by LN in the hope of changing the course of this disease,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia. “Our extensive clinical program, including results from both the AURA and AURORA trials, provides strong support for the profile of voclosporin as a novel treatment for lupus nephritis, and we are rapidly advancing our U.S. commercial strategy and infrastructure to support a potential launch early next year.”\n\n\nLawrence Mandt, Senior Vice President of Quality and Regulatory Affairs, at Aurinia commented, “The excellent Phase 3 clinical results enabled the highly experienced Aurinia team to produce and submit a quality submission for voclosporin ahead of our projections. We now look forward to further dialogue in the coming months with the agency regarding acceptance of the filing and priority review, and a potential approval date in early 2021.”\n\n\nAbout Voclosporin\n\n\nVoclosporin, an investigational drug, is a novel a...