Rivaroxaban (Xarelto) New Drug Application Submitted to U.S. FDA for Pediatric Use in Treatment and Prevention of Venous Thromboembolism (VTE)

VTE (Image source: youthbiomed.home.blog)

June 27, 2021 /BioonBIOON/ --Bayer(Bayer) recently announced that its development partner, Janssen Research & Development, a Johnson & Johnson (JNJ) company, has submitted to the U.S. Food and Drug Administration (FDA) filed a New Drug Application (NDA), willThe oral anticoagulant Xarelto (rivaroxaban) is used for the treatment of pediatric patients.

Xarelto is an oral Factor Xa inhibitor. This NDA seeks approval of Xarelto for two pediatric indications, including a new, weight-based, age-appropriate oral suspension formulation: (1) for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years of age, following at least 5 days of initial parenteral anticoagulant therapy. (2) for thromboprophylaxis in pediatric patients aged ≥2 years with congenital heart disease who have undergone the Fontan procedure.

If approved,Xarelto will be the only oral factor Xa inhibitor for pediatric patients in the United States.For these two potential indications, Xarelto dosing is based on body weight, and patients may take the oral suspension or tablet.

Current guidelines are limited, recommending standard anticoagulation therapy for pediatric patients with thrombosis or at risk of thrombosis recurrence, which requires injections, dietary restrictions, and regular laboratory monitoring. Currently, for pediatric patients with congenital heart disease who have undergone the Fontan procedure, there is still noFDAApproved anticoagulant therapy.

Earlier this year, Xarelto was approved in Canada, the European Union (including the UK), Japan, and Switzerland: for the treatment of VTE and prevention of VTE recurrence in pediatric patients aged 18 years and older following at least 5 days of initial parenteral anticoagulation therapy. Bayer also plans to submit an application in the EU for a pediatric indication of Xarelto for thrombosis prophylaxis following Fontan surgery.

Dr. Christian Rommel, Head of Research & Development and Member of the Executive Board at Bayer, stated: “Submitting this application in the United States is an important step toward helping to address the burden of venous thromboembolism, and will provide physicians with a weight-based dosing option for pediatric patients. The oral Xarelto suspension will eliminate the need to manipulate adult dosage forms, and significantly reduce the number of injections required for anticoagulation therapy and blood sampling.”

This application is based on evidence from adequate and well-controlled studies of Xarelto in adult patients, as well as two Phase 3 trials of Xarelto in pediatric patients.Clinical Trialdata: (1) EINSTEIN-Jr, a trial that previouslyDiagnosisconducted in pediatric patients with VTE; (2) UNIVERSE, which will be conducted in pediatric patients at risk for VTE who have recently undergone the Fontan procedure.Notably, EINSTEIN-Jr is the largest clinical trial completed to date evaluating the treatment of VTE in pediatric patients, and UNIVERSE is the first to assess the prevention of thromboembolism by NOACs in pediatric patients with congenital heart disease following the Fontan procedure.Clinical Trial。

VTE affects individuals of all age groups. Currently, the treatment of pediatric VTE typically relies on intravenous anticoagulants and requires laboratory monitoring and dose adjustments. To date, pediatric anticoagulation regimens have been primarily based on observational data and extrapolation from adult data.

Rivaroxaban is the most widely indicated non-vitamin K antagonist novel oral anticoagulant (NOAC) worldwide., marketed under the trade name Xarelto (Bairuituo). To date,Xarelto has been approved for 9 therapeutic indications., indications vary by country. Compared with other NOACs, Xarelto provides protection for a broad range of patients with venous thromboembolism (VTE) and arterial thromboembolism (VAT): (1) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors; (2) for the treatment of pulmonary embolism (PE) in adults; (3) for the treatment of deep vein thrombosis (DVT) in adults; (4) for the prevention of recurrent DVT and PE in adults; (5) for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery; (6) for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective knee replacement surgery; (7) in combination with aspirin monotherapy or aspirin plus clopidogrel/ticlopidine for the prevention of atherothrombotic events in adult patients with elevated cardiac biomarkers following an acute coronary syndrome; (8) for the prevention of atherothrombotic events in adult patients with chronic coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischemic events; (9) for the treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in pediatric patients under 18 years of age following at least 5 days of initial parenteral anticoagulant therapy.

Approved indications may vary by country; however, across all indications, rivaroxaban has been approved in more than 130 countries. Since its launch in 2008, over 86 million patients worldwide have been treated.

Rivaroxaban was discovered by Bayer and is currently being co-developed with Janssen Research & Development. Xarelto® is marketed by Bayer outside the United States and by Janssen Pharmaceuticals, Inc. in the United States. In 2020, global sales of Xarelto reached $7.5 billion. (Bioon.com)

Original Source:Rivaroxaban application submitted to U.S. FDA for approval to treat VTE and to prevent VTE in children