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Boehringer Ingelheim‘s anti-deep vein thrombosis (DVT) and pulmonary embolism (PE) drug Pradaxa is now available in the UK following European Medicines Agency (EMA) approval.

The EMA approved Pradaxa (dabigatran etexilate) in June for treatment and prevention of recurrence of DVT and PE. Approval is supported by data from three Phase III clinical trials that evaluated the efficacy of Pradaxa compared with Warfarin.

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Data from a fourth clinical trial demonstrated reduction in the risk of recurrent DVT and PE in patients treated with Pradaxa, compared with placebo.

The clinical trials have also showed that patients with DVT or PE had lower rates of bleeding when treated with Pradaxa than with Warfarin.

"The clinical trials have also showed that patients with DVT or PE had lower rates of bleeding when treated with Pradaxa than with Warfarin."

Boehringer Ingelheim claims that Pradaxa has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant.

Boehringer Ingelheim UK medical director Dr Charles de Wet said: "We are delighted at the European Commission’s decision to approve Pradaxa as it has demonstrated efficacy in the treatment of DVT and PE and prevention of recurrence, while also offering convenience through a fixed dose regimen that doesn’t require routine anticoagulation monitoring.

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"We are confident this decision will be similarly welcomed by both patients and clinicians."

The US Food and Drug Administration had approved Pradaxa earlier this year for circulation in the country.

A direct thrombin inhibitor, Pradaxa has been in the market for more than six years to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for primary prevention of venous thromboembolism in patients who have undergone total hip or total knee replacement surgery.

Image: Ball-and-stick model of dabigatran etexilate molecule. Photo: courtesy of MarinaVladivostok.