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Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis
- FDA grants Priority Review and sets PDUFA date of January 22, 2021 - VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)-- Aurinia Pharmaceuticals
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- FDA grants Priority Review and sets PDUFA date of January 22, 2021 -\n\n VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)--\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 that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) 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). The FDA has granted Priority Review for the NDA, which provides an expedited six month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021. The FDA has also informed the Company that they are not currently planning to hold an advisory committee meeting to discuss the application. The FDA has the option to change this decision based on review of the pending NDA.\n\n\n“People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia. “We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021.”\n\n\nPriority review is granted to therapies that the FDA determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition. Under PDUFA, a Priority Review targets a review time of six months compared to a standard review time of 10 months. Voclosporin was also granted Fast Track designation by the FDA in 2016.\n\n\nThe NDA for voclosporin is supported by data from a substantial global clinical program including two pivotal studies, Phase 3 AURORA and Phase 2 AURA-LV. Additional AURORA study data was recently presented at the EULAR and ERA-EDTA virtual conferences, which provided further supportive detail into pre-specified subgroup analyses and changes in kidney function.\n\n\n\n\nAbout Voclosporin\n\n\nVoclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor...