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Veloxis Pharmaceuticals announces positive two-year results from pivotal phase 3 study of Envarsus XR (tacrolimus extended-release tablets) in de novo kidney transplant patients


Monday, 23 Jun 2014 10:49am EDT 

Veloxis Pharmaceuticals A/S:Announces positive two-year results from pivotal phase 3 study of Envarsus XR (tacrolimus extended-release tablets) in de novo kidney transplant patients.Study 3002 was a randomized, double-blind and double-dummy Phase 3 study evaluating once-daily Envarsus XR compared to twice-daily Prograf in 543 de novo kidney transplant patients.Primary endpoint was non-inferiority of a composite endpoint of treatment failure that was evaluated after 12 and 24 months of treatment.Similar to one-year results, Envarsus XR demonstrated non-inferiority to Prograf on the primary endpoint at the two year time point.