This article is more than 5 years old. Information may no longer be current.
FDA advisory committee cites favorable risk/benefit profile for oral anticoagulant
Click Here to Manage Email Alerts
The FDA’s Cardiovascular and Renal Drugs Advisory Committee determined yesterday that rivaroxaban (Xarelto, Bayer AG and Johnson & Johnson), an investigational oral anticoagulant, has a favorable 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 favorable risk/benefit profile, according to an Ortho-McNeil press release.
“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,” Peter DiBattiste, MD, vice president of Johnson & Johnson Pharmaceutical Research and Development LLC, said in the press release. “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 the advisory committee meeting this week included comprehensive results from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program, including four pivotal Phase III studies that involved more than 12,500 patients. These studies compared oral rivaroxaban with injected enoxaparin (Lovenox, Sanofi Aventis) for the prevention of DVT and PE in patients undergoing either total hip (RECORD1 and RECORD2 trials) or knee (RECORD3 and RECORD4 trials) replacement surgery.
In a pre-specified pooled analysis of these trials, which included head-to-head comparisons with enoxaparin as well as a comparison of extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin, there was a statistically significant lower incidence in the primary efficacy endpoint of total venous thromboembolism (VTE), according to the press release. The researchers reported that 4.3% of rivaroxaban-treated patients and 9.4% of enoxaparin-treated patients had VTE.
The overall rates of major bleeding, the primary safety endpoint, were less than 1% in the total treatment duration pool (0.4% of rivaroxaban-treated patients and 0.2% of enoxaparin-treated patients, P = 0.0076), according to the press release.
Johnson & Johnson Pharmaceutical Research and Development submitted the New Drug Application for rivaroxaban on July 28, 2008. If the FDA approves the application, Ortho-McNeil will commercialize rivaroxaban in the United States. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts, according to the press release.