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.”
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
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