KALA - Aurinia Files NDA And Other News: The Good Bad And Ugly Of Biopharma
Aurinia Files Application for Voclosporin Approval
Aurinia Pharmaceuticals Inc. (AUPH) announced that it has submitting a New Drug Application for voclosporin for treating kidney inflammation. The company submitted the data obtained from a global clinical program including the pivotal Phase 3 Aurora study and the pivotal Phase 2 Aura LV study along with the application. Currently, there is no FDA-approved treatment for lupus nephritis. The drug candidate has the potential to become the first FDA-approved therapy for treating lupus nephritis.
Aurinia has also applied for Priority Review, which may help in considerably shortening