FDA gives Janssen green light for 2 new indications of Xarelto

The Food and Drug Administration has given Janssen the green light for two pediatric indications for Xarelto (rivaroxaban): the treatment of venous thromboembolism and reduction in the risk of recurrent VTE in patients from birth to less than age 18 years old after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged 2 years old and older with congenital heart disease who have undergone the Fontan procedure.

Xarelto is the only direct oral anticoagulant FDA-approved for primary prevention of clots in pediatric patients following the Fontan procedure and the only DOAC in the U.S. to offer an oral suspension formulation for flexible, body weight-adjusted dosing options for pediatric patients. 

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"Historically, there has been limited guidance and options for healthcare providers on how to help reduce potentially serious, even fatal, blood clots and related events in young children," said Andrew Van Bergen, pediatric cardiologist, Advocate Children's Hospital. "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."

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 U.S. for pediatric patients in mid-January 2022. The oral tablets are currently available in the U.S. for appropriate pediatric patients.  

"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," said Andrea Baer, executive director of The Mended Hearts, a patient advocacy organization whose program Mended Little Hearts serves patients and families with congenital heart disease. "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."

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Xarelto now has 11 indications.

"Today's FDA approval marks two new Xarelto indications for pediatric patients, an often underrecognized, but especially important patient population," said James List, global therapeutic area head, Cardiovascular, Metabolism, & Retina, Janssen Research & Development. "At Janssen, we are committed to addressing unmet medical needs and the approval of the 10th and 11th indications for Xarelto underscores its capability in reducing the risk of blood clots and cardiovascular events in patients from young to old and with a variety of conditions."