Envarsus XR continues to perform as expected in Phase III trial of Kidney Transplant patients-Veloxis Pharma

Veloxis Pharmaceuticals has announced that two-year results of the pivotal Phase III clinical trial, Study 3002, of Envarsus XR (tacrolimus extended-release) in de novo Kidney Transplant patients continued to demonstrate non-inferiority compared to Prograf (tacrolimus) from Astellas Pharma. Study 3002 was a randomized, double-blind and double-dummy Phase III study evaluating once-daily Envarsus XR compared to twice-daily Prograf in 543 de novo kidney transplant patients; the primary endpoint was non-inferiority of a composite endpoint of treatment failure that was evaluated after 12 and 24 months of treatment. The primary safety and efficacy time point was at the end of Year 1; these results were previously reported by Veloxis on June 27, 2013. Similar to one-year results, Envarsus XR demonstrated non-inferiority to Prograf on the primary endpoint at the two year time point.

Similar incidence of adverse events and predefined potentially clinically significant laboratory parameters were reported for Envarsus XR and Prograf after two years of treatment and the renal function was similar between the two treatment groups. The study results demonstrated that during long-term outpatient therapy from Month 12 onwards, Envarsus XR patients continued to require a daily dose that was approximately 20 to 25 percent lower than patients receiving Prograf. Data were presented at the World Transplant Congress.