Ortho-McNeil announced that the US Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee has determined that rivaroxaban, a novel, investigational, oral anticoagulant, has a favourable risk-benefit profile for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip replacement or knee replacement surgery.
The advisory committee agreed by a 15-2 vote that the available clinical data demonstrate a favourable risk-benefit profile.
"The robust data from our clinical trials support the effectiveness of rivaroxaban in the prevention of dangerous blood clots following hip or knee replacement surgery," said Peter DiBattiste, vice president, Johnson & Johnson Pharmaceutical Research and Development, LLC. "We are very pleased that the advisory committee voted in support of the risk-benefit profile of rivaroxaban shown in our studies. We appreciate the thoroughness of the advisory committee's review and we will continue to work with the FDA as they finalize their review."
Data presented at advisory committee meeting included comprehensive results from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial programme, including four pivotal phase-III studies that involved more than 12,500 patients.
J&JPRD submitted the NDA for rivaroxaban on July 28, 2008. If approved by the FDA, Ortho-McNeil will commercialize rivaroxaban in the US. The US Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts.
The extensive programme of clinical trials supporting possible approval of rivaroxaban by healthcare regulatory authorities makes rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world at present.
Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals Inc (OMJPI), a Johnson & Johnson company, is committed to providing innovative, high-quality prescription medicines and resources for healthcare providers and their patients in hospitals and other care facilities.