The European Committee for Medicinal Products for Human Use (CHMP) has recommended for approval of Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. The decision of the European Commission on the approval is expected before the year-end.

“Rivaroxaban is the novel oral anticoagulant with the broadest range of indications. The recommendation by the CHMP to approve rivaroxaban for this additional use is an important milestone towards improved patient management in the treatment of pulmonary embolism,” said Dr Kemal Malik, Member of the Bayer HealthCare executive committee and head of global development.

The CHMP recommendation to approve rivaroxaban for the treatment of PE and the prevention of recurrent DVT and PE in adults is based on the important clinical findings from the pivotal, global phase III EINSTEIN-PE study. With 4,833 patients enrolled, EINSTEIN-PE is the largest study ever conducted in the acute treatment of PE. The study compared the oral single-drug solution of rivaroxaban 15 mg twice daily for three weeks followed by 20 mg once daily with the current dual drug approach of subcutaneous enoxaparin followed by a VKA. Patients were treated for either three, six or 12 months. Rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis (DVT) and non-fatal or fatal PE, without the need for laboratory monitoring. The overall bleeding rates were similar between the treatment groups, but importantly rivaroxaban was associated with significantly lower rates of major bleeding. The results from this study were published in the New England Journal of Medicine in April this year.

EINSTEIN-PE is one of three phase III studies in the global EINSTEIN programme that evaluated the safety and efficacy of rivaroxaban in the treatment of venous thromboembolism in almost 10,000 patients. The other two trials – EINSTEIN-DVT and EINSTEIN-EXT – were published together in the New England Journal of Medicine in December 2010. In December 2011, Xarelto (rivaroxaban) received European Commission approval for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT in adults.

Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.

Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto.

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.