Bayer and Johnson & Johnson have presented impressive late-stage data on their blood thinner Xarelto as a treatment of pulmonary embolism and in preventing recurrent venous blood clots.
Results from the Phase III EINSTEIN-PE 4,833-patient study have been presented at the American College of Cardiology meeting in Chicago which show that Xarelto (rivaroxaban) was as effective and safe as the current dual drug approach of subcutaneous enoxaparin, Sanofi's Lovenox, followed by warfarin, in treating patients with acute symptomatic pulmonary embolism (PE) and preventing them from developing a secondary venous blood clot (venous thromboembolism or VTE). Xarelto demonstrated similar overall bleeding rates, but was associated with significantly lower rates of major bleeding versus the current standard regimen.
The results "convincingly demonstrate that rivaroxaban offers clinicians a simple, single-drug solution to the initial treatment of PE and the long-term prevention of recurrent VTE, which is as effective as the current dual-drug approach and equally well tolerated," said Alexander Turpie, professor of medicine at McMaster University, Hamilton, Canada. He added that "these new findings are of particular importance given the appalling level of morbidity and mortality associated with venous thromboembolism in Europe and the USA and the frequency of recurrence".
Kemal Malik, head of global development at Bayer HealthCare, noted that following the recent European approval of Xarelto in DVT treatment, "these results reinforce the clinical importance of rivaroxaban in treating the even more dangerous pulmonary blood clots, and preventing their recurrence". He added that the firms are planning to file the drug for marketing authorisation in this indication during the second quarter of this year.
The PE indication could add up to $600 million-$1 billion to Xarelto's peak sales, observers believe.