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Aurinia Pharmaceuticals Inc.has completed the rolling submission to the FDA for voclosporin as a potential treatment for lupus nephritis.
Aurinia Pharmaceuticals Inc.has announced the completion of the rolling submission of a New Drug Application (“NDA”) to the FDA for voclosporin as a potential treatment for lupus nephritis , a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
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.