Janssen’s Xarelto Receives FDA Approval for Two Pediatric Venous Thromboembolism Indications

December 20, 2021—The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the FDA has approved two pediatric indications for Xarelto (rivaroxaban): (1) the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to < 18 years after at least 5 days of initial parenteral (injected or intravenous) anticoagulant treatment and (2) thromboprophylaxis in children aged ≥ 2 years with congenital heart disease who have undergone the Fontan procedure.

In 2021, Janssen’s development partner, Bayer, received approval for Xarelto in Canada, the European Union, the United Kingdom, Japan, Switzerland, and various Latin American countries for the treatment of VTE and prevention of VTE recurrence in the pediatric population, from birth to adolescents less than 18 years after at least five days of initial parenteral anticoagulation treatment.

According to the company, Xarelto is a direct oral anticoagulant (DOAC) approved by the FDA for primary prevention of clots in pediatric patients after the Fontan procedure and is offered in the United States as an oral suspension formulation for flexible, body weight-adjusted dosing options for pediatric patients. It now has 11 indications in the United States.

Janssen noted that the oral suspension formulation will be administered through a color-coded dosing device that was designed to help minimize dosing errors and is expected to become available in the United States for pediatric patients in mid-January 2022. The oral tablets are currently available in the United States for appropriate pediatric patients.

The company’s application for approval was based on evidence from 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.

Andrew Van Bergen, MD, pediatric cardiologist at Advocate Children's Hospital in Oak Lawn, Illinois, commented in the company’s press release, “Historically, there has been limited guidance and options for health care providers on how to help reduce potentially serious, even fatal, blood clots and related events in young children. We have had to adjust adult doses of standard anticoagulation therapies, which are both burdensome and uncomfortable for patients, and require frequent monitoring. Now that Xarelto is FDA-approved with weight-based dosing options, either as tablets or liquid formulation, a convenient option is available allowing flexibility to tailor the treatment for my patients. This is a major advancement in antithrombotic care for those patients under the age of 18.”

Andrea Baer, MS, BCPA, Executive Director of The Mended Hearts, Inc, added, “When a child is experiencing health challenges, learning that they are also at risk for a blood clot can feel overwhelming for the patient, and also their parents or caregivers. Knowing that there is now an FDA-approved oral treatment option to reduce the risk of blood clots that’s easy and may be more comfortable than injections to administer may help ease that burden.” The Mended Hearts is a patient advocacy organization whose program Mended Little Hearts serves patients and families with congenital heart disease.