Patients in Europe at risk of blood clot disorders will now have access to Bayer’s Xarelto after the drug gained further approvals from regulatory authorities.
The European Commission has added the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults to the medicine’s EU indications, which already include the treatment of DVT and the prevention of recurrent DVT and PE in adults following an instance of acute DVT.
It is already cleared to prevent venous thromboembolism (VTE) in patients who are undergoing surgery to replace a hip or knee, and to prevent stroke in patients with non-valvular atrial fibrillation (AF).
The latest approval gives Xarelto (rivaroxaban) an edge over its rival anticoagulant, Boehringer’s Pradaxa (dabigatran etexilate), which is only available in Europe for the latter two prevention indications.
Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, commented on the benefits for healthcare systems in treating PE, which involves a blood clot in a person’s deep vein or leg or pelvis detaching itself and travelling to the lungs.
“Approximately one in 10 patients who suffer a pulmonary embolism dies, and concerningly, PE remains a leading cause of hospital death,” he said.
“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.”
Eve Knight, co-founder and CEO of the charity AntiCoagulation Europe (ACE), also mentioned the benefits for patients, who now have a simpler single-drug oral treatment option, instead of the current standard treatment of daily injections of a heparin.
“The current standard of care can be complicated, which adds to the stress and burden on the patient so today’s news is great for patients,” she said.
“With the approval of rivaroxaban for the treatment and prevention of PE, patients at last have the choice of a simple, fast and effective treatment option.”
The European approval follows clearance from the US FDA earlier this month for Xarelto’s use in the treatment of DVT or PE, as well as to reduce the risk of recurrent DVT and PE following initial treatment.