Posted by Michael Wonder on 21 Jul 2020
Aurinia announces U.S. FDA acceptance of the filing of new drug application and priority review for voclosporin for the treatment of lupus nephritis
21 July 2020 - FDA grants priority review and sets PDUFA date of 22 January 2021 .
Aurinia Pharmaceuticals today announced that the U.S. FDA has accepted the filing of its new drug application for voclosporin, as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the auto-immune disease systemic lupus erythematosus.
The FDA has also informed the Company that they are not currently planning to hold an advisory committee meeting to discuss the application. The FDA has the option to change this decision based on review of the pending new drug application.
