Filing seeks update to prescribing information to include additional dosage of XARELTO® to reduce risk of recurrent VTE
RARITAN, NJ, USA I April 28, 2017 I Janssen Research & Development, LLC (Janssen) announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the prescribing information for XARELTO® (rivaroxaban) to add a 10 mg dose to reduce patients’ risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy. This application is based on data from the EINSTEIN CHOICE study.
VTE includes deep vein thrombosis (DVT), a blood clot in a deep vein (often in the legs), and pulmonary embolism (PE), a clot that travels to the lung. It affects more than 900,000 Americans each year, with about one-third of these occurrences being fatal.[i] Once a person experiences a VTE, they are at increased risk of a repeat occurrence.[i] Guidelines currently recommend standard anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like XARELTO®, for three months or longer.[ii]
“For those people who have had a VTE and stop anticoagulant therapy, as many as 10 percent of them will experience another VTE within one year and 20 percent within three years,” said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. “Our hope is to offer two dose options for continued treatment with XARELTO® to the many people at risk of having another VTE.”
If the application is approved, healthcare professionals who are managing patients with
VTE will be able to prescribe either XARELTO® 10 mg (once daily) or the currently-approved 20 mg dose (once daily) after patients have received at least six months of standard anticoagulation therapy. XARELTO® currently has six indications approved by the FDA, including the treatment of VTE and reduction of the risk of recurrent VTE.
The EINSTEIN CHOICE study showed that patients with VTE who were already treated with six to 12 months of standard anticoagulation therapy and then received either XARELTO® 10 mg or 20 mg once daily for up to an additional 12 months of extended treatment, had significantly fewer recurrent VTE compared to those taking aspirin 100 mg once daily. All three treatment groups had low rates of major bleeding. People who required extended anticoagulation at therapeutic doses were not included, as the objective of the study was to investigate those patients for whom the treating physician was uncertain about the need for continuing anticoagulant therapy.
EINSTEIN CHOICE was presented during a Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials session at the American College of Cardiology’s 66th Annual Scientific Session (ACC.17) in March and simultaneously published in The New England Journal of Medicine.
About EINSTEIN CHOICE
EINSTEIN CHOICE was a Phase 3, global, randomized, double-blind, superiority study that compared the efficacy and safety of two doses of XARELTO® (10 mg and 20 mg once daily) with aspirin 100 mg once daily for the continued management of VTE in people with confirmed DVT or PE who were initially treated with anticoagulant therapy for six to 12 months. The study met its primary efficacy endpoint, finding both XARELTO® doses (10 mg and 20 mg) to be superior to aspirin in reducing the risk of recurrent VTE. There were 3,365 patients from 31 countries included in the study analysis.
About EXPLORER
EINSTEIN CHOICE is part of the industry-leading EXPLORER clinical research program for XARELTO®. The EXPLORER program is unmatched by any oral anticoagulant in the NOAC class in its size, scope and ambition. A collaborative effort between Janssen and Bayer, EXPLORER seeks to generate important clinical evidence on the safety and efficacy of XARELTO® and its potential role in addressing critical unmet medical needs. A number of the studies are designed to seek additional indications or expand the label for XARELTO®. By the time of its completion, more than 275,000 patients will have participated in the EXPLORER clinical development 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 with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.
XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.
Trademarks are those of their respective owners.
Janssen and Bayer together are developing rivaroxaban.
For more information about XARELTO®, visit www.xarelto.com.
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 at @JanssenUS.
[i] (2017 April 6). Venous Thromboembolism (Blood Clots) Data & Statistics. Retrieved from https://www.cdc.gov/ncbddd/dvt/data.html
[ii] Kearon C, Akl EA, Ornelas J, et al. Antithrombotic Therapy for VTE Disease CHEST Guideline and Expert Panel Report. CHEST 2016;149(2):315-52.
SOURCE: Janssen
Post Views: 75
Filing seeks update to prescribing information to include additional dosage of XARELTO® to reduce risk of recurrent VTE
RARITAN, NJ, USA I April 28, 2017 I Janssen Research & Development, LLC (Janssen) announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the prescribing information for XARELTO® (rivaroxaban) to add a 10 mg dose to reduce patients’ risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy. This application is based on data from the EINSTEIN CHOICE study.
VTE includes deep vein thrombosis (DVT), a blood clot in a deep vein (often in the legs), and pulmonary embolism (PE), a clot that travels to the lung. It affects more than 900,000 Americans each year, with about one-third of these occurrences being fatal.[i] Once a person experiences a VTE, they are at increased risk of a repeat occurrence.[i] Guidelines currently recommend standard anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like XARELTO®, for three months or longer.[ii]
“For those people who have had a VTE and stop anticoagulant therapy, as many as 10 percent of them will experience another VTE within one year and 20 percent within three years,” said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. “Our hope is to offer two dose options for continued treatment with XARELTO® to the many people at risk of having another VTE.”
If the application is approved, healthcare professionals who are managing patients with
VTE will be able to prescribe either XARELTO® 10 mg (once daily) or the currently-approved 20 mg dose (once daily) after patients have received at least six months of standard anticoagulation therapy. XARELTO® currently has six indications approved by the FDA, including the treatment of VTE and reduction of the risk of recurrent VTE.
The EINSTEIN CHOICE study showed that patients with VTE who were already treated with six to 12 months of standard anticoagulation therapy and then received either XARELTO® 10 mg or 20 mg once daily for up to an additional 12 months of extended treatment, had significantly fewer recurrent VTE compared to those taking aspirin 100 mg once daily. All three treatment groups had low rates of major bleeding. People who required extended anticoagulation at therapeutic doses were not included, as the objective of the study was to investigate those patients for whom the treating physician was uncertain about the need for continuing anticoagulant therapy.
EINSTEIN CHOICE was presented during a Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials session at the American College of Cardiology’s 66th Annual Scientific Session (ACC.17) in March and simultaneously published in The New England Journal of Medicine.
About EINSTEIN CHOICE
EINSTEIN CHOICE was a Phase 3, global, randomized, double-blind, superiority study that compared the efficacy and safety of two doses of XARELTO® (10 mg and 20 mg once daily) with aspirin 100 mg once daily for the continued management of VTE in people with confirmed DVT or PE who were initially treated with anticoagulant therapy for six to 12 months. The study met its primary efficacy endpoint, finding both XARELTO® doses (10 mg and 20 mg) to be superior to aspirin in reducing the risk of recurrent VTE. There were 3,365 patients from 31 countries included in the study analysis.
About EXPLORER
EINSTEIN CHOICE is part of the industry-leading EXPLORER clinical research program for XARELTO®. The EXPLORER program is unmatched by any oral anticoagulant in the NOAC class in its size, scope and ambition. A collaborative effort between Janssen and Bayer, EXPLORER seeks to generate important clinical evidence on the safety and efficacy of XARELTO® and its potential role in addressing critical unmet medical needs. A number of the studies are designed to seek additional indications or expand the label for XARELTO®. By the time of its completion, more than 275,000 patients will have participated in the EXPLORER clinical development 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 with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.
XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.
Trademarks are those of their respective owners.
Janssen and Bayer together are developing rivaroxaban.
For more information about XARELTO®, visit www.xarelto.com.
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 at @JanssenUS.
[i] (2017 April 6). Venous Thromboembolism (Blood Clots) Data & Statistics. Retrieved from https://www.cdc.gov/ncbddd/dvt/data.html
[ii] Kearon C, Akl EA, Ornelas J, et al. Antithrombotic Therapy for VTE Disease CHEST Guideline and Expert Panel Report. CHEST 2016;149(2):315-52.
SOURCE: Janssen
Post Views: 75
