Aurinia Completes Submission of New Drug Application to the U.S. Food & Drug Administration for Voclosporin for the Treatment of Lupus Nephritis
- Category: Proteins and Peptides
- Published on Tuesday, 26 May 2020 12:26
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- Potential for voclosporin to become the first FDA-approved therapy for the treatment of lupus nephritis -
- NDA Application supported by extensive global clinical program including the pivotal Phase 3 AURORA study and the pivotal Phase 2 AURA LV study -
VICTORIA, Canada & ROCKVILLE, MA, USA I May 26, 2020 I Aurinia 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.
“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.”
Lawrence 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.”
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (CNI) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (versus cyclosporine A), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label.
About Lupus Nephritis
Lupus nephritis (“LN”) is an inflammation of the kidney caused by Systemic Lupus Erythematosus (“SLE”) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder. The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. Unlike SLE, LN has straightforward disease outcomes, where an early reduction in proteinuria correlates with positive long-term outcomes. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced eGFR, and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (“ESRD”), thus making LN a serious and potentially life-threatening condition.
Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing the investigational drug voclosporin for the treatment of lupus nephritis, other proteinuric diseases and dry eye syndrome. The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub in Rockville, Maryland, and focuses its development efforts globally.
SOURCE: Aurinia Pharmaceuticals