Xarelto gets new EU approval
pharmafile | November 21, 2012 | News story | Sales and Marketing | AF, Bayer, DVT, Xarelto
Bayer’s oral anticoagulant Xarelto has extended its licence in Europe to treat pulmonary embolism (PE) and prevent recurrent deep vein thrombosis (DVT) in adults.
The European Commission’s move mirrors that by the FDA earlier this month, when the US regulator similarly expanded Xarelto (rivaroxaban)’s indications.
PE happens when a blood clot in the leg or pelvis travels to the lung via the heart: if it blocks one of the pulmonary arteries, death is likely to result without rapid treatment.
Current treatments include the use of a low-molecular weight heparin, which in the UK is usually Sanofi’s injectable Lovenox (enoxaparin) with an oral vitamin K antagonist (VKA).
But Bayer says Xarelto works as fast as Lovenox and can do the job on its own – making it a less complex option for doctors and patients.
Dr Kemal Malik, Bayer’s head of global development, 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.”
Xarelto was already approved in Europe prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) and to prevent venous thromboembolism (VTE) in patients having hip or knee replacement surgery.
The approval for PE and the prevention of recurrent DVT and PE is based on the global Phase III EINSTEIN-PE study.
It compared oral Xarelto 15 mg twice-daily for three weeks, followed by 20 mg once-daily, with subcutaneous enoxaparin plus a VKA.
Patients were treated for three, six or 12 months and Xarelto was comparable to standard therapy in reducing the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic DVT and non-fatal or fatal PE, without the need for laboratory monitoring.
Overall bleeding rates were similar, but Xarelto was associated with lower rates of major bleeding. Janssen Pharmaceuticals markets the drug in the US.
Adam Hill
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