If approved, this will add to the five existing VTE indications for XARELTO® – the most studied anticoagulant available to the most groups of patients
Despite being largely preventable, VTE remains a significant risk for the eight million Americans with acute medical illnesses
TITUSVILLE, NJ, USA I December 14, 2018 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) for XARELTO® (rivaroxaban) to the U.S. Food and Drug Administration (FDA) for the prevention of venous thromboembolism (VTE), or blood clots, in medically ill patients. This application is based on combined data from the Phase 3 MAGELLAN and MARINER trials, which evaluated XARELTO® for the prevention of VTE in these patients during their hospital stay and immediately following discharge.
Approximately eight million Americans are hospitalized each year for acute medical illnesses, which include serious yet common conditions like heart failure, stroke, respiratory insufficiency, infectious diseases and inflammatory diseases. Hospital-associated VTE is the leading cause of premature death and disability in this population,i and the risk of VTE also extends to the outpatient setting. In fact, 67 percent of recently hospitalized patients who develop a VTE do so within one month of discharge.ii Guidelines currently recommend that people at risk of VTE receive anticoagulants in the hospital but advise against routine anticoagulant use beyond the hospital stay.
“Despite being at high risk of VTE for up to six weeks when leaving the hospital, less than four percent of patientsiii with acute medical illnesses are prescribed anticoagulant therapy to prevent VTE after they leave the hospital,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “We hope to make XARELTO® available for these patients to prevent a VTE for the time that they remain at risk, beginning with hospitalization through at-home recovery.”
XARELTO® already has five approved VTE indications, including the treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), reduction of the risk of recurrent DVT and PE, and primary prevention of DVT, which may lead to PE, in people who have just had hip or knee replacement surgery. In October 2017, the FDA approved a new dose regimen of 10 mg XARELTO® once-daily for reducing the continued risk for recurrent VTE after completion of at least six months of initial therapy.
About MAGELLAN and MARINER
Published in 2013, the Phase 3 MAGELLAN study evaluated the use of XARELTO® 10 mg in preventing VTE in acute medically ill patients, starting with their hospital stay and continuing through post-hospital discharge. The study met its two co-primary endpoints, with XARELTO® demonstrating non-inferiority to enoxaparin in short-term use (10 ± 4 days) and superiority in long-term use (35 ± 4 days) compared to short-term use of enoxaparin followed by placebo. The combined rates of major and non-major clinically relevant bleeding were higher in those treated with XARELTO®.
Building on the foundation provided by the results from MAGELLAN, the Phase 3 MARINER trial was conducted in a similar population of medically ill patients, evaluating XARELTO® for the prevention of VTE and VTE-related death following hospital discharge. While MARINER demonstrated that XARELTO® did not reduce the composite endpoint of VTE and VTE-related death, it did significantly reduce symptomatic VTE with consistent and favorable safety, reinforcing XARELTO®‘s positive benefit-risk profile.
About EXPLORER
MAGELLAN and MARINER are part of the EXPLORER clinical research program for XARELTO®. A collaborative effort between Janssen and its development partner Bayer, EXPLORER has generated important clinical evidence on the safety and efficacy of XARELTO®. Many studies in the program are designed to seek additional indications or expand the label for XARELTO® to benefit more patients in need of therapies for their cardiovascular (CV) disease. By the time of its completion, more than 275,000 patients will have participated in the EXPLORER program, other completed and ongoing clinical trials, investigative registries and non-interventional studies.
WHAT IS XARELTO®?
XARELTO® is a prescription medicine used to:
- reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body
- treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
- reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months
- help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery
XARELTO® is also used with low dose aspirin to:
- reduce the reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral arterial disease (a condition where the blood flow to the legs is reduced)
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at @JanssenUS. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
i Spyropoulos AC, Raskob GE. New paradigms in venous thromboprophylaxis of medically ill patients. Thromb Haemost. 2017;117(9):1662-70.
ii Spencer FA, Lessard D, et al. Venous thromboembolism in the outpatient setting. Arch Intern Med. 2007;167(14):1471-75.
iii Mahan CE, Fisher MD, Mills RM, et al. Thromboprophylaxis patterns, risk fac- tors, and outcomes of care in the medically ill patients population. Thromb Res 2013; 132: 520–526.
F Janssen
Post Views: 380
If approved, this will add to the five existing VTE indications for XARELTO® – the most studied anticoagulant available to the most groups of patients
Despite being largely preventable, VTE remains a significant risk for the eight million Americans with acute medical illnesses
TITUSVILLE, NJ, USA I December 14, 2018 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) for XARELTO® (rivaroxaban) to the U.S. Food and Drug Administration (FDA) for the prevention of venous thromboembolism (VTE), or blood clots, in medically ill patients. This application is based on combined data from the Phase 3 MAGELLAN and MARINER trials, which evaluated XARELTO® for the prevention of VTE in these patients during their hospital stay and immediately following discharge.
Approximately eight million Americans are hospitalized each year for acute medical illnesses, which include serious yet common conditions like heart failure, stroke, respiratory insufficiency, infectious diseases and inflammatory diseases. Hospital-associated VTE is the leading cause of premature death and disability in this population,i and the risk of VTE also extends to the outpatient setting. In fact, 67 percent of recently hospitalized patients who develop a VTE do so within one month of discharge.ii Guidelines currently recommend that people at risk of VTE receive anticoagulants in the hospital but advise against routine anticoagulant use beyond the hospital stay.
“Despite being at high risk of VTE for up to six weeks when leaving the hospital, less than four percent of patientsiii with acute medical illnesses are prescribed anticoagulant therapy to prevent VTE after they leave the hospital,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “We hope to make XARELTO® available for these patients to prevent a VTE for the time that they remain at risk, beginning with hospitalization through at-home recovery.”
XARELTO® already has five approved VTE indications, including the treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), reduction of the risk of recurrent DVT and PE, and primary prevention of DVT, which may lead to PE, in people who have just had hip or knee replacement surgery. In October 2017, the FDA approved a new dose regimen of 10 mg XARELTO® once-daily for reducing the continued risk for recurrent VTE after completion of at least six months of initial therapy.
About MAGELLAN and MARINER
Published in 2013, the Phase 3 MAGELLAN study evaluated the use of XARELTO® 10 mg in preventing VTE in acute medically ill patients, starting with their hospital stay and continuing through post-hospital discharge. The study met its two co-primary endpoints, with XARELTO® demonstrating non-inferiority to enoxaparin in short-term use (10 ± 4 days) and superiority in long-term use (35 ± 4 days) compared to short-term use of enoxaparin followed by placebo. The combined rates of major and non-major clinically relevant bleeding were higher in those treated with XARELTO®.
Building on the foundation provided by the results from MAGELLAN, the Phase 3 MARINER trial was conducted in a similar population of medically ill patients, evaluating XARELTO® for the prevention of VTE and VTE-related death following hospital discharge. While MARINER demonstrated that XARELTO® did not reduce the composite endpoint of VTE and VTE-related death, it did significantly reduce symptomatic VTE with consistent and favorable safety, reinforcing XARELTO®‘s positive benefit-risk profile.
About EXPLORER
MAGELLAN and MARINER are part of the EXPLORER clinical research program for XARELTO®. A collaborative effort between Janssen and its development partner Bayer, EXPLORER has generated important clinical evidence on the safety and efficacy of XARELTO®. Many studies in the program are designed to seek additional indications or expand the label for XARELTO® to benefit more patients in need of therapies for their cardiovascular (CV) disease. By the time of its completion, more than 275,000 patients will have participated in the EXPLORER program, other completed and ongoing clinical trials, investigative registries and non-interventional studies.
WHAT IS XARELTO®?
XARELTO® is a prescription medicine used to:
- reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body
- treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
- reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months
- help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery
XARELTO® is also used with low dose aspirin to:
- reduce the reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral arterial disease (a condition where the blood flow to the legs is reduced)
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at @JanssenUS. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
i Spyropoulos AC, Raskob GE. New paradigms in venous thromboprophylaxis of medically ill patients. Thromb Haemost. 2017;117(9):1662-70.
ii Spencer FA, Lessard D, et al. Venous thromboembolism in the outpatient setting. Arch Intern Med. 2007;167(14):1471-75.
iii Mahan CE, Fisher MD, Mills RM, et al. Thromboprophylaxis patterns, risk fac- tors, and outcomes of care in the medically ill patients population. Thromb Res 2013; 132: 520–526.
F Janssen
Post Views: 380
