RARITAN, N.J.—Janssen Pharmaceuticals, Inc. recentlyannounced that its drug candidate XARELTO (rivaroxaban tablets) has receivedU.S. Food and Drug Administration (FDA) approval. XARELTO is a novel,once-daily oral anticoagulant indicated for the prevention of deep veinthrombosis (DVT), which can cause a pulmonary embolism (PE) in patientsundergoing knee or hip replacement surgery.
"XARELTO has a proven clinical benefit over one of today'smost widely used options in preventing these potentially life-threatening bloodclots, and the use of a once-daily pill may play an essential role in helpingto simplify clinical practice," said Louis M. Kwong, M.D., Professor ofOrthopedic Surgery at Harbor-UCLA Medical Center, in a statement. Kwong playeda part in the rivaroxaban clinical trials program for this indication. Theapproval, Kwong added, offers patients a new option in protecting themselvesafter surgery.
According to the American Academy of Orthopedic Surgeons,more than 800,000 Americans have knee or hip replacement surgery every year,surgeries that have an increased risk for DVT, a blood clot that forms within adeep vein. If the clot breaks off, it can travel through the bloodstream to thelungs and potentially become a PE, which can have serious consequences.
Becauseof the risks associated with DVT, the American College of Chest Physiciansrecommends blood thinners for patients immediately after orthopedic replacementsurgery and for extended use after leaving the hospital—at least 10 days for kneereplacement patients and up to 35 days for hip replacement patients. DVT and PEare the leading causes of re-hospitalization cases after joint replacementsurgeries.
"The use of blood thinners has been shown to safely andeffectively help keep people from developing preventable blood clots," saidAlan Brownstein, Chief Executive Officer of the National Blood Clot Alliance,in a press release about the drug's approval. "The FDA approval of a new bloodthinner, XARELTO, offers a new option for patients seeking knee or hipreplacement surgery, and we encourage people to discuss with their physiciansthe risk of blood clots and which blood thinner offers optimal protection aspart of their pre-surgical consultation."
XARELTO is approved as a once-daily, 10 mg dose to be takenfor 35 days following hip replacement and 12 days following knee replacementsurgery. In its Phase III clinical trials, it demonstrated greater efficacythan enoxaparin and a similar safety profile, and it is approved in over 110countries. While Janssen Pharmaceuticals holds the marketing rights for XARELTOin the United States, the drug has also been launched in more than 80 countriesby Bayer HealthCare, whose U.S. sales force supports Janssen's in detailing thedrug.
"Shorter hospital stays following hip and knee replacementsurgeries have made the prevention of venous blood clots an outpatient issue,and XARELTO provides a safe and effective oral treatment option that can beeasily transitioned from use in hospital to home," said Paul Chang, M.D., VicePresident, Medical Affairs, Internal Medicine, Janssen Pharmaceuticals, in apress release regarding the drug's approval. "We're pleased to make XARELTOtablets available to physicians to help them better protect their patients fromthese highly preventable surgical complications."
SOURCE: Janssen Pharmaceuticals, Inc. press release