Boehringer-Ingelheim Now RE-LYing On Pradaxa Approval In Stroke Prevention
Executive Summary
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
You may also be interested in...
FDA Supports Pradaxa Approval, But Without Superiority Claim
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.
Heart Attack Signal Is Likely Focus For Panel Review Of Boehringer Ingelheim's Pradaxa
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.
Momentum Grows For Novel Oral Anticoagulants Out To Replace Warfarin
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