Next Step Taken for Potential Lupus Nephritis Treatment, Voclosporin
Aurinia Pharmaceuticals Inc. announced today that it has successfully submitted a New Drug Application (NDA) to the Food and Drug Administration for its drug, voclosporin for the potential treatment of lupus nephritis (LN). The NDA application is submitted to the FDA to request approval for marketing a new drug in the United States.
Voclosporin is a type of immunosuppressant drug known as a calcineurin inhibitor (CNI) that has been shown to be stronger, more predictable and safer than some similar drugs on the market today. The drug has no clinically significant interactions with mycophenolate mofetil (MMF), a treatment considered to be part of the current standard of care for lupus in the U.S. Research supports that voclosporin, in addition to MMF and corticosteroids, is effective in the treatment of LN. Additionally, efficacy of the drug has been proven through two landmark studies, the Phase 3 AURORA study and the Phase 2 AURA LV study.
There are currently no FDA-approved treatments for LN. Aurinia’s submission included a request for Priority Review and, if granted, would shorten FDA review to eight months from time of submission for a potential approval date in early 2021. The Lupus Foundation of America will continue to monitor and report on the drug’s review process. Learn more about medications used to treat lupus.