An Advisory Committee to the U.S. Food and Drug Administration (FDA) met today to discuss the new drug application (NDA) for Bayer’s rivaroxaban, a novel, oral anticoagulant taken as one tablet, once-daily for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery. The FDA utilized the expertise of the Advisory Committee members as part of their review process, and asked the committee members to address a number of scientific and clinical questions. At the end of the meeting, the Advisory Committee agreed by a vote of 15-2 that “available clinical data demonstrated a favorable risk-benefit profile”.
“Today’s scientific discussion was highly productive, and we are very pleased that the panel recognized the strong dataset which supports the favorable benefit-risk profile of rivaroxaban,” said Dr. Kemal Malik, member of the Bayer HealthCare Executive Committee and Chief Medical Officer.
Data presented at today’s Advisory Committee meeting included results from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program, which involved more than 12,500 patients in four Phase III studies. The studies compared oral rivaroxaban with injected enoxaparin for the prevention of venous thromboembolism (VTE), which comprises DVT and PE, in patients undergoing either total hip (RECORD1 and 2) or total knee (RECORD3 and 4) replacement surgery. The RECORD1, 2 and 3 studies compared rivaroxaban, dosed 10 mg once-daily, against enoxaparin dosed once-daily at 40 mg. RECORD4 evaluated rivaroxaban (10 mg once-daily) against the U.S.-approved dosing regimen for enoxaparin for knee replacement surgery (30 mg twice-daily).
“The data from the RECORD trials show a greater relative risk reduction for rivaroxaban versus the comparator, enoxaparin, in preventing total VTE after total hip and knee replacement surgery,” said Dr. A.G.G. Turpie, Principal Investigator in the RECORD program, Professor of Medicine, McMaster University, Canada. “The committee’s positive vote concerning benefit-risk supports rivaroxaban’s potential to reduce patients’ risk of complications after such surgery.”
The NDA for rivaroxaban was submitted by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. on July 28, 2008. The Advisory Committee’s recommendations are not binding, but FDA reviewers will consider the panel’s recommendation in its assessment of the NDA for rivaroxaban. If approved by the FDA, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will commercialize rivaroxaban in the U.S. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts. Bayer HealthCare is exclusively responsible for the marketing of rivaroxaban in countries outside the U.S.
Source: Bayer Healthcare