EMA approved the drug Pradaxa for treatment and prophylaxis of DVT and pulmonary embolism

The European medicines Agency (EMA) has approved the drug PradaxaБ•? (dabigatran etexilate) for the treatment and prevention of DVT and pulmonary embolism. Management of quality control food and drug administration USA approved use of the drug, Pradaxa in deep vein thrombosis and pulmonary embolism in April God. Deep vein thrombosis and pulmonary embolism can be very dangerous - one of the three patients with pulmonary embolism die within three months. 4 out of 10 patients are faced with recurrent venous thromboembolism within 10 years after the first case.

"We are pleased that the European Commission has approved use of the drug, PradaxaБ•? in deep vein thrombosis and pulmonary embolism. This once again confirms the well-studied positive profile of the risk-benefit of drug Pradaxa confirmed in clinical trials involving almost 10,000 patients with deep vein thrombosis and pulmonary embolism, and more than 40 000 patients for other indications," said Professor Klaus Arc, senior Vice President of medical Affairs Boehringer Ingelheim. "Access to this new drug is critical for patients - we know of pulmonary embolism due to deep vein thrombosis is still the leading cause of preventable in-hospital mortality".

The approval of the European Commission followed the positive decision of the Committee for medicinal products for medical use European Agency for medicines. Approval is based on the results of three important clinical phase III studies compared with warfarin - RE-COVER I RE-COVER II, RE-MEDY, confirming the efficacy of Pradaxa in the treatment and prevention of recurrent DVT and TALA-4. In the fourth study - RE-SONATE data showed a 92% reduction in the risk of recurrence of thrombosis in patients taking the drug Pradaxa, in comparison with placebo. The results showed that patients with DVT and pulmonary embolism treated with the drug Pradaxa, significantly less experienced with bleeding than patients taking warfarin, indicating an overall favorable safety profile. Preparation of Pradaxa has the longest history of clinical trials, which included patients with deep vein thrombosis and pulmonary embolism among all new oral anticoagulants.

The approval of a new indication for dabigatran - a significant step forward for patients with deep vein thrombosis and pulmonary embolism and their doctors. The results of clinical trials indicate that dabigatran has a better safety profile compared with warfarin, with similar efficiency from the point of view of treatment and prevention of recurrent DVT and pulmonary embolism. Additional advantages, such as ease of use and simple fixed dosage regimen, also meet the needs of patients and physicians," said Professor Stavros, Konstantinidis, doctor of medical Sciences, Deputy Director for scientific research at the Centre for thrombosis and hemostasis Johannes Gutenberg University (Mainz, Germany).

Preparation of Pradaxa easy to use for patients, as it does not require routine laboratory testing, neither mandatory correction during treatment. Patients with DVT and pulmonary embolism can start taking the drug Pradaxa in a fixed dosage of 150 mg 2 times a day after starting treatment injectable anticoagulants.

The drug has been available for over 6 years, and more than 100 countries have approved its use for reducing the risk of stroke and systemic embolism in patients with atrial fibrillation nalapannie etiology. Pradaxa at a dose of 150 mg twice a day is the only new oral anticoagulant in the clinical trial (study RE-LY) showed significant compared with warfarin decrease the incidence of ischemic and hemorrhagic stroke in patients with atrial fibrillation nalapannie etiology. Ischemic stroke, which accounts for nine out of ten strokes in patients with atrial fibrillation can lead to devastating consequences, including disability and death. The study RE-LY was an international clinical study phase III type PROBE (prospective, randomized, open clinical trial with blind assessment of outcomes) comparing two fixed doses of the direct thrombin inhibitor of dabigatran of etexilate (110 mg 2 times a day and 150 mg 2 times per day), each of which was assigned blind, open-warfarin.

Preparation of Pradaxa was also approved for the primary prevention of venous thromboembolism (General term for deep vein thrombosis and pulmonary embolism) in patients who underwent elective surgery for total hip or knee.

About drug Pradaxa (dabigatran etexilate)

Currently for drug Pradaxa in Russia registered the following indications:

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