AUPH

Voclosporin

Lupus Nephritis

PDUFA

Exp Date

Jan 22, 2021

Amp Volatility Score

Catalyst Info & Data Links

TITLE: Voclosporin for Lupus Nephritis - PDUFA

  • ClinicalTrial.gov (NCT03597464): Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2)


WHAT IS THE NEXT CATALYST EVENT?

  •  PDUFA


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA


PRESS RELEASES

 POSTERS

  • TBA


PRESENTATIONS


PUBLICATIONS



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)

MECHANISM OF ACTION/RATIONALE

  • 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

Updated by HC

AUPH, Voclosporin, Lupus Nephritis, lupus, AURORA2

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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Recent Posts

See What The Community Is Saying - Click To See Full Post

AUPH Ph3 data in lupus nephrit...

AUPH reported encouraging phase 3 results in December (12/4/19) in lupus nephritis, an inflammation of the kidney caused by SLE. Its calcineurin inhibitor drug candidate voclosporin met its primary en...

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