Posted by Michael Wonder on 16 Mar 2020
Aurinia Pharmaceuticals initiates rolling submission of a new drug application to the U.S. Food and Drug Administration for voclosporin in the treatment of lupus nephritis
16 March 2020 - Company remains on track to complete submission by the end of the second quarter 2020.
Aurinia Pharmaceuticals announced today that the company has initiated a rolling submission of its new drug application to the U.S. FDA for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis.
The rolling submission allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis. Aurinia has submitted the non-clinical module and expects to complete the submission of all modules by the end of the second quarter of 2020.
