The approval has been granted for Xarelto to prevent 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.
The approval was based on data from the Phase 3 clinical programme, which included the MAGELLAN and MARINER studies. Both trials assessed rivaroxaban to prevent VTE in acutely ill medical patients during hospitalisation and immediately following discharge.
MAGELLAN study, which was published in 2013, assessed the use of Xarelto in preventing VTE in hospitalised patients with an acute medical illness and restricted mobility.
The trial achieved its two co-primary efficacy endpoints, with Xarelto showing non-inferiority to enoxaparin in short-term use and superiority in long-term use compared to short-term use of enoxaparin followed by placebo.
Published in 2018, MARINER study assessed Xarelto to prevent VTE and VTE-related death following hospital discharge compared to placebo.
Xarelto considerably reduced symptomatic VTE with consistent and favourable safety, while it did not reduce the composite endpoint of VTE and VTE-related death in the study.
Rivaroxaban is said to be the most indicated non-vitamin K antagonist oral anticoagulant (NOAC) across the world and is commercialised under the brand name Xarelto. It is approved for more venous and arterial thromboembolic (VAT) conditions compared to other NOACs.
Janssen Research & Development cardiovascular and metabolism global therapeutic area head Dr James List said: “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.
“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.”
In August this year, Bayer secured FDA approval for its Nubeqa (darolutamide) to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC).