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Bayer submits Xarelto for approval to treat DVT in US

Says bloodthinner shown to be safer alternative to current treatments

Bayer has submitted Xarelto to the US Food and Drug Administration (FDA) to seek approval for a new indication for the oral anticoagulant to treat deep vein thrombosis (DVT) or pulmonary embolism (PE) and to prevent recurrent venous thromboembolism (VTE).

If approved this would open up a large, lucrative market for the bloodthinner. The US Centers for Disease Control and Prevention estimates 300,000 to 600,000 people in the US get DVT or PE each year, and that 60,000 to 100,000 people die as a result.

Xarelto (rivaroxaban), which is co-marketed by Johnson & Johnson (J&J), is currently only available in the US to reduce the risk of stroke and blood clots in people with atrial fibrillation and to reduce the risk of blood clots in people who have just had knee or hip replacement surgery.

The new submissions are supported by data from the global EINSTEIN programme, involving almost 10,000 patients.

This programme comprised three phase III studies that demonstrated the oral single-dose drug was as effective as Sanofi's Lovenox (enoxaparin) plus a vitamin K antagonist, but offered a simpler dosing regimen and a superior safety profile with regards to incidents of major bleeding.

Also helping Bayer's case is the drug's approval in Europe for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT in adults, which it received in December 2011.

A positive decision from the FDA would give the edge to Bayer over Boehringer Ingelheim, whose own bloodthinner Pradaxa (dabigatran etexilate) is available in both the US and Europe for the prevention of stroke in patients with AF, as well as to prevent blood clots following surgery to replace a hip or knee in Europe.

Pradaxa has also been associated with more than 250 patient deaths as a result of serious bleeding, although the EMA said it would not add further restrictions to the drug's label.

Both Pradaxa and Xarelto are part of a new generation of oral anticoagulants that are set to replace warfarin, with both drugs working in different ways: Xarelto is a Factor Xa inhibitor while Pradaxa is a direct thrombin inhibitor.

In addition the the US marketing applications, Bayer has regulatory filings underway in Europe to expand the Xarelto's indication to cover treatment of PE and the prevention of recurrent DVT and PE, also based on studies in the EINSTEIN programme.

3rd May 2012

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