Aurinia Completes NDA and Requests Priority Review of Voclosoporin by FDA for Lupus Nephritis

May 28, 2020

The Lupus Research Alliance is pleased to share that Aurinia Pharmaceuticals Inc submitted a New Drug Application (NDA) to the U.S. FDA for voclosporin as a potential treatment for lupus nephritis with request for a priority review. Lupus nephritis is one of the most common complications of systemic lupus erythematosus, a serious inflammation of the kidneys. There are currently no FDA-approved treatments for lupus nephritis.

The application from Aurinia includes a request for priority review.  According to the FDA, priority review designation is given to evaluation of drugs that if approved would be significant improvements in the safety or effectiveness of the treatment for serious conditions. The goal of the FDA is to review and act upon applications granted priority designation within six months compared to the longer standard review which can take one year.

Click here for press release from Aurinia Pharmaceuticals.