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Aurinia Pharmaceuticals Initiates Rolling Submission of a New Drug Application to the FDA for Voclosporin in the Treatment of Lupus Nephritis

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced today that the Company has initiated a Rolling Submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for voclosporin, a next-generation calcineurin inhibitor for th

Benzinga · 03/16/2020 10:06

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced today that the Company has initiated a Rolling Submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis ("LN"). 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.

"Following a positive pre-NDA meeting with the FDA in February, we are pleased to initiate our rolling NDA submission to the Agency, a critical step toward making voclosporin available to patients as soon as possible. We look forward to working with the FDA throughout the process," commented Larry Mandt, Senior Vice President, Quality and Regulatory Affairs at Aurinia.

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.