Voclosporin: First Approval

Drugs. 2021 Apr;81(5):605-610. doi: 10.1007/s40265-021-01488-z.

Abstract

Voclosporin (Lupkynis) is an oral calcineurin inhibitor immunosuppressant that is being developed by Aurinia Pharmaceuticals. In January 2021, based on positive results from the pivotal phases II and III trials, oral voclosporin received its first approval in the USA for use in combination with a background immunosuppressive therapy regimen for adults with active lupus nephritis. Voclosporin is also being explored for the novel coronavirus disease 2019 (COVID-19) in kidney transplant recipients. This article summarizes the milestones in the development of voclosporin leading to this first approval for lupus nephritis.

Publication types

  • Review

MeSH terms

  • Animals
  • COVID-19 / complications
  • COVID-19 Drug Treatment*
  • Calcineurin Inhibitors / pharmacokinetics
  • Calcineurin Inhibitors / pharmacology
  • Calcineurin Inhibitors / therapeutic use*
  • Cyclosporine / pharmacokinetics
  • Cyclosporine / pharmacology
  • Cyclosporine / therapeutic use*
  • Drug Approval
  • Humans
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / pharmacology
  • Immunosuppressive Agents / therapeutic use*
  • Kidney Transplantation*
  • Lupus Nephritis / drug therapy

Substances

  • Calcineurin Inhibitors
  • Immunosuppressive Agents
  • voclosporin
  • Cyclosporine