AUPH

Voclosporin

Lupus Nephritis

Stage (next event)

Next Event

Expected Date

PDUFA

Approval Decision

Jan 22, 2021

7/22/2020 FDA accepted NDA filing and granted priority review - PDUFA set for 1/22/21

Catalyst Info & Data Links

MORE INFORMATION

• NDA filing accepted by FDA and priority review granted

• AURORA 2 extension study data expected Q4 2021

• Investor Presentation (Slides 7-11)

DRUG HISTORY

• 11-12-2020 Aurinia Pharmaceuticals to Present at the 2020 Jefferies Virtual London Healthcare Conference

• U.S. Food & Drug Administration grants Priority Review for voclosporin and sets PDUFA date of January 22, 2021

• 11-09-2020 Aurinia  Presents Integrated Time to Renal Response Data from the AURA-LV and  AURORA Trials, along with Voclosporin Drug-Drug Interaction Data at ACR  Convergence 2020

• 07-21-2020 FDA Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis

• 05-26-2020 Submission of NDA to the U.S. FDA for Voclosporin for the Treatment of Lupus Nephritis

• 05-14-2020 Pre-NDA Meeting with the U.S. FDA and Rolling New Drug Application (“NDA”) Submission

• 03-16-2020 Initiates Rolling Submission of a New Drug Application to the U.S. FDA for Voclosporin in the Treatment of Lupus Nephritis

PRESENTATIONS

• Phase 2 AURA-LV Data Presentation

• 05-2020: Coporate Overview (slide 14-22)

• 06-2020: Phase 3 Study Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis

PUBLICATIONS

• 2017: Calcineurin Inhibitors in the Treatment of Lupus Nephritis: A Hare Versus Turtle Story? JASN , 28 (12) 3435-3437; doi: 10.1681/ASN.2017080830

• 2018: Sin FE, Isenberg D. An evaluation of voclosporin for the treatment of lupus nephritis. Expert Opin Pharmacother.:1613-1621. doi:10.1080/14656566.2018.1516751

• 2019: A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis. Kidney Int. 95(1):219-231. doi:10.1016/j.kint.2018.08.025

Mechanism of Action

• Vaclosporin is a structural analog of cyclosporine A 

• Immunosuppressant with a synergistic and dual mechanism of action 

• It binds to calcineurin through the latch region which blocks IL-2 expression and T-cell mediated immune responses and stabilized podocytes in the kidney

• Click here to learn more

COMPETITORS

• RC18 (Telitacicept) - RemeGen

• Abatacept (Orencia) - Bristol-Myers Squibb

• Anifrolumab - AstraZeneca/MedImmune

• Blisibimod - Anthera/Amgen

• Lupuzor - ImmuPharma

MARKET

• ~63,000 patients with LN in U.S. (source)

FS

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AUPH, Voclosporin, Lupus Nephritis, lupus, AURORA2, Aurinia

Prior Data (click to view full image)

Trial Design / Revenue (click to view full image)