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Johnson & Johnson submits new drug application to the FDA for anticoagulant
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Johnson & Johnson Pharmaceutical Research & Development LLC has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for approval of rivaroxaban as a medication to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Rivaroxaban (Xarelto, Bayer HealthCare/Johnson & Johnson) is a novel anticoagulant taken as a tablet once daily.
If and when marketing authorization has been granted in the United States, rivaroxaban will be commercialized by Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., according to a Bayer news release on Wednesday.
Rivaroxaban is the first oral anticoagulant to demonstrate superior efficacy over the U.S.-approved, twice-daily injectable regimen of enoxaparin (Lovenox; Sanofi-Aventis), with a similar safety profile and no significant increase in major bleeding.
Upon FDA approval, rivaroxaban will be the first novel oral anticoagulant introduced in the U.S. market in more than 50 years, according to the press release.
"We are pleased to see rivaroxaban take an important step toward regulatory approval so swiftly after demonstrating unparalleled success in the robust clinical trial program," Kemal Malik, MD, member of the Bayer HealthCare Executive Committee, said in the news release. "Current standards of anticoagulation therapy have limitations and new preventative therapies are needed. We are now on the cusp of revolutionizing the care of patients undergoing hip and knee replacement surgery."
In addition to the FDA submission, filings are under review with regulatory agencies around the world. On July 24, rivaroxaban was recommended for approval in Europe for venous blood clot prevention after hip or knee replacement surgery.
The new drug application in the United States is supported by data from the RECORD clinical program, in which more than 12,500 orthopedic patients have been investigated - the largest ever conducted in the prevention of venous thromboembolism in patients undergoing knee or hip replacement surgery. It comprised four Phase III clinical trials that compared rivaroxaban with enoxaparin.
For more information:
- www.news.bayer.com
- www.orthosupersite.com/view.asp?rID=29757
- www.orthosupersite.com/view.asp?rID=28998