Boehringer is expected to make available the 75mg dose of Pradaxa in pharmacies in the coming weeks.
Pradaxa received approval from the US Food and Drug Administration (FDA) on 19 October 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Boehringer Cardiovascular and Metabolic Disorders marketing vice president Wa’el Hashad said that they have already received a positive response from the atrial fibrillation community and that the new treatment would soon be available for patients with the condition who are at increased risk for stroke.
Phase III RE-LY trial of Pradaxa demonstrated benefits over warfarin, the current standard of care, including a significant reduction in the risk of stroke and systemic embolism.
Boehringer medical director Christopher Corsico said that treatment with Pradaxa does not require routine blood monitoring or related dose adjustments. Pradaxa has the potential to impact the treatment paradigm for patients with non-valvular atrial fibrillation.