Aurinia Pharmaceuticals Inc (AUPH)

[Lunacy_John Galt]

“We are thrilled with the outcome and direction received from the FDA. With a clear path forward for voclosporin’s development to treat LN, we are mobilizing quickly to initiate the Phase III study in Q2 next year, fulfilling our goal of improving the long-term outcomes for patients with this disease,” added Charles Rowland, Aurinia’s Chief Executive Officer.

http://www.investopedia.com/news/aurinia-aligns-fda-lupus-drug-auph/

Aurinia Confirms Receipt of FDA End of Phase 2 Meeting Minutes

DOWNLOAD AS PDF DECEMBER 13, 2016
-Minutes are consistent with previously issued preliminary responses from FDA

-Single Phase 3 clinical trial to be conducted with 23.7mg BID voclosporin for the treatment of active lupus nephritis (LN)

-Trial on track to commence in Q2 2017

VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)(TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced that it has received the final End of Phase II (EOP2) meeting minutes from the U.S. Food & Drug Administration Division of Pulmonary, Allergy and Rheumatology Products. The minutes are consistent with the preliminary responses that were issued to the Company prior to the meeting which took place on October 25, 2016.

Aurinia believes this Phase 3 clinical trial will support a New Drug Application (NDA) submission.

“We have thoroughly reviewed the final EOP2 meeting minutes provided to us by FDA, which are consistent with our previous assessment and are moving as quickly as we can to initiate the AURORA trial,” commented Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at Aurinia.

“We are pleased to be working closely with FDA to bring this treatment to market and helping as many people as possible suffering from this debilitating disease,” added Charles Rowland, Aurinia’s Chief Executive Officer. “Our clinical team has been working on preparations for this important trial to meet our goal of enrolling the first patient in Q2 2017. In the meantime, we expect the AURA 48-week secondary endpoint durability of renal response data in Q1 next year.”