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Drug Discovery and Development

Xarelto wins two additional pediatric indications

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JanssenJanssen (NYSE:JNJ) has received FDA approval for two new indications for the blockbuster blood thinner Xarelto (rivaroxaban).

The first new indication relates to treating venous thromboembolism (VTE, or blood clots) and reducing the risk of recurrent VTE in pediatric individuals from birth to less than 18 years after at least five days of parenteral anticoagulant treatment.

The second involves using rivaroxaban as a thromboprophylaxis in children at least two years older with congenital heart disease who underwent the Fontan procedure.

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

Last year, the drug brought in almost $6.5 billion in international revenue.

To win the two new approvals, Janssen submitted data from the EINSTEIN-Jr and UNIVERSE Phase 3 trials.

Bayer worked with Janssen to develop rivaroxaban.

In related news, a recent study found that older adults taking rivaroxaban for a type of irregular heart rhythm had higher rates of bleeding and stroke compared to patients taking the blood-thinner Eliquis (apixaban), according to Reuters.

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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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