The FDA has accepted Aurinia Pharmaceuticals’ (NASDAQ:AUPH) New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis, an inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
The Agency has granted Priority Review for the NDA and has assigned a PDUFA target action date of January 22, 2021.
The FDA currently do not plan to hold an advisory committee meeting to discuss the application.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.