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Thursday, October 22, 2020

Aurinia's voclosporin integrated data shows benefit in lupus

  • Aurinia Pharmaceuticals (NASDAQ:AUPH) has announced that integrated efficacy and pharmacokinetic data from AURA-LV and AURORA pivotal trials of voclosporin in lupus nephritis (LN) were presented at the American Society of Nephrology Kidney Week.
  • Integrated data from 534 patients from both the trials demonstrated that 268 patients with LN treated with voclosporin in combination with mycophenolate mofetil (MMF) and low-dose steroids achieved statistically superior and faster Renal Response rates compared to 266 patients treated with MMF and steroids alone.
  • Renal Response rate of 43.7% was achieved with voclosporin compared to 23.3% in the control arm at one year and at six months (voclosporin 31.7%; placebo 20.3%).
  • Voclosporin was shown to inhibit calcineurin in a dose-dependent manner, thus potentially eliminating the need for therapeutic drug monitoring
  • The data presented was submitted as part of voclosporin’s marketing application filed to the FDA.
  • https://seekingalpha.com/news/3625090-aurinias-voclosporin-integrated-data-shows-benefit-in-kidney-inflammation

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