FDA grants rolling submission to Luveniq for lupus nephritis.- Aurinia Pharmaceuticals

Aurinia Pharmaceuticals announced that the Company has initiated a Rolling Submission of its New Drug Application to the FDA for Luveniq (voclosporin), a next-generation calcineurin inhibitor for the treatment of lupus nephritis. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis. Aurinia has submitted the Nonclinical Module and expects to complete the submission of all Modules by the end of the second quarter of 2020.

Comment: Voclosporin was granted Fast Track designation by the FDA in 2016, with a Priority Review to be requested as part of the complete NDA submission anticipated by the end of Q2 2020.