FDA Approves BI’s Pradaxa, First New Oral Anticoagulant Since Warfarin

The FDA’s approval of Pradaxa, the first new oral anticoagulant approved since warfarin in the 1950s, means a likely blockbuster drug for German drugmaker Boehringer Ingelheim (BI), analysts say. The FDA approved Pradaxa (dabigatran etexilate) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. An estimated 2.3 million Americans suffer from the condition. The approval came as no surprise as the agency’s Cardiovascular and Renal Drugs Advisory Committee unanimously recommended approval last month.
Drug Industry Daily