Positive Results Of 3002 Study: LCP-Tacro
Monday, July 1, 2013 - 04:50
in Health & Medicine
Veloxis Pharmaceuticals announced that LCP-Tacro successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002. The Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf as the comparator, met its primary efficacy and primary safety endpoints. The study was conducted under a Special Protocol Agreement with the FDA and the results are considered pivotal for the planned U.S. regulatory filing expected to occur in the second half of 2013. read more