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European Medicines Agency recommends approval of novel oral anticoagulant, dabigatran etexilate (Pradaxa®)

Boehringer Ingelheim have announced that the Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency has issued a positive opinion to recommend marketing authorisation of their novel, oral direct thrombin inhibitor, dabigatran etexilate. The CHMP recommends approval of dabigatran etexilate for the prevention of venous thromboembolic events in patients who have undergone total hip replacement surgery or total knee replacement surgery.

The positive opinion is a recommendation to the European Commission that authorization to market the drug should be granted in the European Union which normally occurs within 67 days.

Patients who have undergone total hip or knee replacement are at high risk of venous thromboembolism (VTE). This risk extends beyond the usual period of hospitalisation, as thromboprophylaxis treatment is often discontinued following discharge due to the complex administration of current anticoagulants. As dabigatran etexilate is given as a fixed oral dose, it can be administered conveniently both in and out of the hospital setting, providing patients with effective protection from potentially dangerous thrombi (blood clots).

Dabigatran etexilate has a rapid onset and offset of action and predictable anticoagulation effect, without the need for coagulation monitoring. It specifically and reversibly inhibits thrombin, the central and essential enzyme in the coagulation cascade responsible for thrombus formation. Dabigatran etexilate exhibits no drug-food interactions and has a low potential for drug-drug interactions.