Janssen bags Xarelto FDA approval to prevent blood clots in acutely ill patients
Xarelto FDA approval : The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US Food and Drug Administration (FDA) for Xarelto (rivaroxaban) for the prevention of venous thromboembolism or blood clots in acutely ill medical patients.
The latest approval for the drug is for the treatment of blood clots in hospitalized acutely ill medical patients who are prone to thromboembolic complications, and who do not face a high risk of bleeding.
Xarelto, which is a direct oral anticoagulant (DOAC), can be started for these patients during hospitalization and continued after their discharge for a recommended period of 31-39 days.
FDA has approved Xarelto in eight indications till date, of which six of them are particularly for the treatment, prevention, and reduction in the risk of recurrence of blood clots among wide variety of patient populations.
Commenting on the latest Xarelto FDA approval, James List – Global Therapeutic Area Head of Janssen Research & Development Cardiovascular & Metabolism, 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.”
Xarelto FDA approval has been driven by the results of a phase 3 clinical program, which includes the Magellan and Mariner studies, featuring more than 20,000 patients with acute medical illness.
Magellan assessed the use of Xarelto for the prevention of blood clots in hospitalized patients with an acute medical illness and having restricted movement, during their hospitalization and after their discharge from the hospital.
Two co-primary efficacy endpoints were met during the late-stage trial with Xarelto showing non-inferiority to enoxaparin, in short term use for 10 ± 4 days, and superiority in the long term use of 35 ± 4 days in comparison with short term use of enoxaparin followed by placebo.
The Phase 3 Mariner trial was also done on acutely ill medical patients. The late-stage trial studied Xarelto’s role in comparison to placebo in the prevention of blood clots and deaths caused by the condition after discharge from the hospital.
In the Mariner trial, Xarelto was shown to have significantly decreased symptomatic blood clotting with consistent and favorable safety.
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