Aurinia completes submission of new drug application to the U.S. FDA for voclosporin for the treatment of lupus nephritis

Aurinia Pharmaceuticals

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.

Read Aurinia Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier