Boehringer-Ingelheim Now RE-LYing On Pradaxa Approval In Stroke Prevention
As Boehringer-Ingelheim scrambles to file its oral anticoagulant Pradaxa with FDA, likely for stroke prevention in patients with atrial fibrillation, physicians already have started weighing the pros and cons of the drug's two possible doses
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Agency charges the Sept. 20 Cardiovascular and Renal Drugs Advisory Committee with evaluating the relative benefit of preventing strokes with the increased risk of bleeding posed by Boehringer Ingelheim's dabigatran.
When FDA's Cardiovascular and Renal Drugs Advisory Committee meets Sept. 20 to consider Boehringer Ingelheim's Pradaxa (dabigatran) for stroke prevention, a significantly higher rate of heart attacks among clinical trial patients compared with warfarin is likely to come up.
The attributes of Merck/Portola's Factor Xa inhibitor betrixaban, and where it fits in the crowded development space of novel anticoagulants, came into sharper focus with the release of new Phase II data at the American College of Cardiology annual meeting