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
- Category: Proteins and Peptides
- Published on Monday, 16 March 2020 15:50
- Hits: 728
- Company remains on track to complete submission by the end of the second quarter 2020 -
VICTORIA, Canada I March 16, 2020 I Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, 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.
Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by diseases with a high unmet medical need. The Company is currently developing an investigational drug for the treatment of LN, focal segmental glomerulosclerosis (“FSGS”) and dry eye syndrome (“DES”). The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally. For further information, see our website at www.auriniapharma.com.
SOURCE: Aurinia Pharmaceuticals