Boehringer Ingelheim says that its experimental blood thinner Pradaxa is safer, more effective and simpler to use than the generic warfarin, a standard therapy for treating patients with erratic heart rates.
Given at a high dose, researchers at the European Society of Cardiology meeting in Barcelona say that Pradaxa prevented more strokes and clots than warfarin without hiking the risk of serious bleeding. And the European developer told Dow Jones that the data gives it a compelling story to present to the FDA in the fourth quarter, when it plans to file for an approval.
"We achieved a 34 percent reduction in the risk for stroke and systematic embolism in patients with atrial fibrillation compared with the standard therapy warfarin," says Boehringer Chairman Andreas Barner.
Boehringer has been positioning Pradaxa to compete for a growing market. Roughly four percent of the population over 60 suffers from atrial fibrillation. And for the past five decades they have had to rely on warfarin, a drug with serious side effects and a problematic history. At a high dose, 1.11 percent of Pradaxa patients experienced a stroke or clot compared to 1.69 percent of warfarin patients. The low-dose group experienced a 1.53 percent rate of strokes and clots. Analysts say that the data should help Boehringer claim a market worth more than a billion euros a year.