janssen_latest_logo_on_sign_closer

FDA approves Janssen’s Xarelto for blood clot prevention

pharmafile | October 15, 2019 | News story | Manufacturing and Production, Sales and Marketing |  FDA, Janssen, US, Xarelto, pharma, thromboembolism 

Janssen’s Xarelto (rivaroxaban) has secured FDA approval for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalised acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding, it has emerged.

In a Phase 3 study examining 20,000 participants with acute mental illness, Xarelto proved itself non-inferior to enoxaparin in sort-term use (ranging from around six to 14 days) and superior in long-term use (ranging from around 31 to 39 days) to short-term use of enoxaparin plus placebo, meeting  the trial’s co-primary endpoints.

In a separate Phase 3 trial, it was found that, while Janssen’s drug failed to VTE and VTE-related death compared to placebo, it did “significantly reduce” symptomatic VTE.

“Preventing blood clots is a critical priority for physicians treating patients with acute medical illnesses, which is why Janssen is pleased that the FDA approved the use of Xarelto to address this often fatal, yet preventable condition,” commented Dr James List, Global Therapeutic Area Head, Cardiovascular & Metabolism at Janssen. “Rather than facing daily injections with older anticoagulants, patients now have a new oral treatment option that will help prevent blood clots, both in the hospital and after hospital discharge.”

Advertisement

Over seven million US citizens are hospitalised with acute illness each year, and these patients are at an increased risk of developing blood clots lasting up to three months, with 80% occurring within the first six weeks.

Matt Fellows

Related Content

Pharma sees climate disruption as growing supply-chain risk

Nine in ten pharmaceutical companies across the UK and G7 countries expect climate-related disruption to …

AI in pharma: From lab development to patient impact

In the decade to 2025, AI use in vaccine development has increased markedly but is …

Cell therapy partnership aims to bring liver disease treatment closer to US patients

Resolution Therapeutics has partnered with the Blood Centers of America (BCA) to support community-based delivery …

The Gateway to Local Adoption Series

Latest content