Janssen submits new drug application to FDA for rivaroxaban to treat VTE in pediatric patients

Xarelto (rivaroxaban)

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced it has submitted a new drug application (NDA) to the Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban) in pediatric patients.

The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis in patients aged two years and older with congenital heart disease who have undergone the Fontan procedure. If approved, Xarelto will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in pediatric patients.

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring VTE with standard anticoagulant therapy, which often requires painful injections, dietary restrictions, and regular laboratory monitoring. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. The limited guidance for managing these patients leaves physicians to extrapolate adult data to infer pediatric dosing and then regularly monitor their patients.

The application is based on evidence from adequate and well-controlled studies of Xarelto in adults as well as data from two Phase 3 clinical trials of Xarelto in pediatric populations: EINSTEIN-Jr, which examined pediatric patients with previously diagnosed VTE, and UNIVERSE, which evaluated pediatric patients who are at risk of VTE after recently undergoing the Fontan procedure.

A press release states that EINSTEIN-Jr, part of the EXPLORER clinical research program, is the largest study completed to date evaluating the treatment of pediatric patients with VTE, and that UNIVERSE is the first clinical trial to examine a direct oral anticoagulant (DOAC) for the prevention of thromboembolism in congenital heart disease post-Fontan pediatric patients.

For both potential indications, Xarelto would be dosed based on body weight, either with an oral suspension formulation or tablets. The oral suspension formulation would be administered through a unique color-coded dosing device that was designed to help minimize dosing errors.

Earlier this year, Janssen’s development partner Bayer received approval in Canada, the European Union including the U.K., Japan, and Switzerland for Xarelto for the treatment of VTE and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least five days of initial parenteral anticoagulation treatment.


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