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NICE gives final approval to Bayer’s Xarelto for use in DVT-PE

Offers safer, easier to use alternative to warfarin

Bayer Xarelto rivaoxaban

Bayer's Xarelto (rivaroxaban) is now available for mainstream use within the NHS in England and Wales to both treat and prevent blood clots, after receiving a final recommendation from UK regulators.

The National Institute for Health and Clinical Excellence (NICE) has approved the drug, which Bayer co-markets with Janssen, as an option for treating deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism in adults diagnosed with acute DVT, after the Institute determined it to be a cost-effective use of NHS resources.

The approval gives patients in England and Wales a potentially safer but just as effective alternative to warfarin, which requires regular monitoring with blood tests, dosing adjustments and the need for patients to restrict their diet because of warfarin's interaction with certain foods.

“Because rivaroxaban does not require frequent blood tests to monitor treatment it represents a potential benefit for many people who have had a DVT, particularly those who have risk factors for recurrence of VTE and who therefore need longer term treatment,” said Professor Carole Longson, NICE Health Technology Evaluation Centre director.

In addition, Xarelto's oral mechanism offers a simpler method of use than current standard care of a dual-drug regimen consisting of low molecular weight heparin (LMWH) administered by subcutaneous injection,followed by warfarin or another vitamin K antagonist.

Bayer now has access to an expanding market, with over46,000 cases of acute DVT in England and Wales during 2012, rising to nearly 50,000 by 2016, according to NICE.

It is also the third NICE approval for Xarelto following positive recommendations for the drug's use in venous thromboembolism and stroke prevention in people with atrial fibrillation.

This gives Bayer the edge over Boehringer Ingelheim, whose rival anticoagulant Pradaxa is currently only available for the latter two indication.

Xarelto is also on its way to gaining approval for entry onto the US market in this DVT and pulmonary embolism indication after receiving a priority review from the Food and Drug Administration (FDA).

25th July 2012

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