FDA Approves Two Pediatric Indications For J&J’s Xarelto

FDA recently approved two pediatric indications for Johnson & Johnson’s direct oral anticoagulant (DOAC), Xarelto.

The agency approved the drug to treat venous thromboembolism (VTE) and to reduce the risk of recurrent VTE in patients from birth to less than 18 years of age after at least five days of initial anticoagulant treatment.

Additionally, Xarelto is approved for thromboprophylaxis in children two years of age and older with congenital heart disease who have undergone the Fontan procedure.

“This FDA approval marks two new Xarelto indications for pediatric patients, an often underrecognized, but especially important patient population,” James List, MD, PhD, global therapeutic area head, cardiovascular, metabolism, & retina at Janssen research & development, said in the announcement.

“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,” List continued.

Current medical guidelines recommend that pediatric patients with or at risk for developing blood clots be treated with standard anticoagulation therapy, such as warfarin or heparin.

Physicians may have to adjust adult doses based on limited data for these therapies for these patients.

Caregivers can administer Xarelto through a color-coded dosing device designed to help minimize dosing errors. The device is expected to become available in mid-January 2022. Currently, the oral tablets are available in the US for appropriate pediatric patients.  

FDA based its approval of Xarelto on two Phase 3 pediatric studies from the EXPLORER clinical research program.

The first trial, EINSTEIN-Jr, is the largest study to date evaluating pediatric patients from birth to under 18 years of age with previously diagnosed VTE. And the second trial, UNIVERSE, is the first to examine a DOAC to prevent VTE in pediatric patients after undergoing the Fontan procedure.

Xarelto now has 11 indications in the US, the most of any DOAC, and is the most studied oral FactorXa inhibitor in its class.

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