Voclosporin, an investigational therapy developed by Canada’s Aurinia Pharmaceuticals, is more effective at treating lupus nephritis (LN) than other calcineurin inhibitors, according to data from the ongoing Phase 2B AURA-LV (AURA) trial (NCT02141672). Dr. James Tumlin, the study’s lead author and clinical investigator, gave a presentation, “Steroid Sparing Efficacy of Voclosporin in…
Aurinia Pharmaceuticals has started a Phase 3 clinical trial of voclosporin, which eliminated an inflammatory kidney condition known as lupus nephritis in more than half of patients tested in a Phase 2b trial. The complete response rate of 49 percent of the patients in the Phase 2b trial was…
Aurinia Pharmaceuticals and Lonza have entered into a long-term manufacturing agreement over the active pharmaceutical ingredient (API) in voclosporin, Aurinia’s investigative drug for diseases that include lupus nephritis (LN). The agreement aims toward providing an eventual commercial supply of voclosporin, and includes its use in an upcoming and possibly pivotal clinical trial in LN…
Aurinia Pharmaceuticals will take its drug candidate voclosporin into a possibly pivotal Phase 3 clinical trial of its efficacy in treating lupus nephritis — kidney disease caused by systemic lupus erythematosus. Following Phase 2 study meetings with the U.S. Food and Drug Administration (FDA), Aurinia believes the new trial will provide…
Aurinia Pharmaceuticals recently announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to voclosporin, a next-generation calcineurin inhibitor under development to treat patients with lupus nephritis (LN) and other autoimmune diseases. LN is a kidney inflammation caused by systemic lupus erythematosus (SLE) in which patients may develop proteinuria,…