Regulators in Europe have given the green light to Bayer's anticoagulant Xarelto for the treatment of pulmonary embolism and the prevention of recurrent deep vein thrombosis.
Approval by the European Commission means that Xarelto (rivaroxaban) is the only oral anticoagulant to get the thumbs-up in this indication. The approval for these new uses is based on data from the EINSTEIN-PE study, with 4,833 patients enrolled, which compared Xarelto 15mg twice-daily for three weeks, followed by 20mg once daily, with the current dual drug approach of subcutaneous enoxaparin (Sanofi's now off-patent Lovenox) followed by a oral vitamin K antagonist.
Patients were treated for three, six or 12 months and Xarelto demonstrated efficacy comparable to that of the current standard therapy. The overall bleeding rates were similar between the treatment groups, but Bayer notes that importantly, Bayer was associated with significantly lower rates of major bleeding.
Kemal Malik, head of global development of Bayer HealthCare, noted that approximately one in 10 patients who suffer a PE dies, and it remains a leading cause of hospital death. He added that this new approval "will bring the benefits of Xarelto to more patients and physicians, where the need for a fast, effective and convenient therapy against blood clots is essential for both acute and long-term treatment".
The company quoted Eve Knight, chief executive of the charity AntiCoagulation Europe, as saying that the current standard of care "can be complicated which adds to the stress and burden on the patient so [the] news is great for patients".
Xarelto has now been approved for a number of indications in Europe, including the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation. Bayer believes the drug, which is partnered with Johnson & Johnson, will be a 2 billion euro product.
The views expressed in the following comments are not those of PharmaTimes or any connected third party and belong specifically to the individual who made that comment. We accept no liability for the comments made and always advise users to exercise caution.