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


DRUG HISTORY


PRESENTATIONS


PUBLICATIONS




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

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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