Last December,’s (NYSE:JNJ) blockbuster blood thinner Xarelto (rivaroxaban) won FDA approval for two new indications for pediatric indications.

The drug now has 11 indications in the U.S., more than any other direct oral anticoagulant (DOAC).

In 2020, the drug generated nearly $6.5 billion in revenue globally.

To learn more about the new indications, we spoke with Dr. James List, global therapeutic area head, cardiovascular, metabolism and retina, Janssen Research and Development, LLC.

Here, Dr. List provides a summary of the new pediatric indications and how the direct-acting anticoagulant (DOAC) compares to rivals.

Drug Discovery & Development: What are the main things prescribing physicians should know about FDA’s approval of two pediatric indications for Xarelto?

Dr. James List

List: Xarelto (rivaroxaban) is the only DOAC 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. This approval offers healthcare providers, children and their families an alternative to injectable anticoagulants that have long been the standard of care.

Xarelto’s oral suspension formulation and weight-based dosing offer convenience and flexibility for healthcare providers to tailor treatment for pediatric patients. The oral suspension formulation will be administered through a color-coded dosing device designed to help minimize dosing errors. The FDA’s approval of these pediatric indications for Xarelto represents a major advancement in antithrombotic care for pediatric patients.

DDD: Could you briefly summarize how Xarelto stands out from other DOACs and Factor Xa anticoagulants?

List: With this latest approval, Xarelto now has 11 indications — the most of any DOAC — and is the most studied oral Factor Xa inhibitor in its class. Xarelto is the only DOAC in the U.S. to offer an oral suspension formulation for flexible, body weight-adjusted dosing options for pediatric patients and the only DOAC approved for primary prevention of clots in pediatric patients following the Fontan procedure.

DDD: Xarelto is now approved for 11 indications. Can you speak to Xarelto’s expanded versatility since it first hit the market?

List: Xarelto has continued to advance the standard of antithrombotic care across a broad range of patients since its initial approval in the U.S. in 2011.

2021 was a significant year for Xarelto with three new FDA approvals — two pediatric VTE indications and an expanded peripheral artery disease (PAD) indication for Xarelto in combination with aspirin to include patients after lower-extremity revascularization (LER) due to symptomatic PAD. Xarelto is the only anticoagulant in 20 years to show significant benefit in patients with PAD who remain at high risk for major thrombotic events, including acute limb ischemia and amputation.

Xarelto is offered as an oral suspension formulation for pediatric patients.

The recent FDA approval of two pediatric indications, Xarelto’s 10^th and 11^th indications, 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.

DDD: How does Xarelto relate to Janssen’s pledge to serve underserved and vulnerable patients?

List: Pediatric patients are an often under-recognized but especially important patient population. While VTE more commonly occurs in adults, blood clots can still be a serious problem in children — affecting approximately 58 per 10,000 of those hospitalized in the U.S., with rates increasing.

The FDA approval of Xarelto is an advancement in antithrombotic care for those under the age of 18, and the oral suspension formulation and weight-based dosing will provide the convenience and flexibility to tailor treatment to pediatric patients.

With this approval, Janssen is continuing to deliver on its promise to develop new, innovative solutions for underrecognized, vulnerable patient groups and is bold in going where others are not to provide solutions that address unmet need.