26 May 2020 - Application supported by extensive global clinical program including the pivotal Phase 3 AURORA study and the pivotal Phase 2 AURA LV study.
Aurinia Pharmaceuticals today announced the completion of the rolling submission of a new drug application to the United States FDA for voclosporin as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the auto-immune disease systemic lupus erythematosus.
There are currently no FDA approved treatments for lupus nephritis. The 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.