Johnson and Johnson presents ‘pivotal’ phase III rivaroxaban data

Johnson & Johnson has announced positive phase III data showing that rivaroxaban to be statistically superior enoxaparin when used to prevent venous thromboembolism (VTE) in patients who have undergone hip replacement surgery.

In the Record1 study, the compound – being developed in conjunction with Bayer HealthCare, was found to demonstrate a 70 per cent relative risk reduction in total VTE and an 88 per cent relative risk reduction in major VTE when compared to enoxaparin.

The duration of thromboprophylaxis in both treatment groups was five weeks, while the primary endpoint of the study was total VTE – which combines DVDT, non-fatal pulmonary embolism and mortality from all causes.

“Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a range of patients who could benefit from the prevention and/or treatment of blood clots,” Johnson & Johnson reports.

It adds that the compound operates at a key stage during the process of coagulation to directly inhibit the working of enzyme Factor Xa.

In August 2007, a report from advisory firm Decision Resources claimed that the safety and delivery enhancements would see the drug surpass Arixtra (fondaparinux sodium) from GSK and become the “clinical gold standard” treatment to prevent VTE in the coming years.