Dabigatran approval wave rides into Canada

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Health Canada, the Canadian health authority, has approved Boehringer Ingelheim’s dabigatran etexilate (Pradax, or sold in the U.S. as Pradaxa), an oral direct thrombin inhibitor for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in whom anticoagulation is appropriate.

This marks the second approval of the anticoagulant following the marketing authorization by the FDA last week.

Health Canada’s approval makes dabigatran available to AF patients in Canada, with the flexibility of two dosing regimens. While overall the 150 mg bid dose is recommended, the 110 mg bid dose is specifically available for elderly patients aged 80 years and above as well as for patients at high risk of bleeding, according to the Ingelheim, Germany-based company.