Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa® (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.
The decision to add the contraindication was made following an interim analysis of results from the Phase II RE-ALIGN™ study in patients with mechanical prosthetic heart valve replacement, a patient population different than the currently labeled indication for PRADAXA. The RE-ALIGN™ study did not enroll any U.S. patients. The interim analysis showed an increased incidence of thromboembolic and bleeding events in this specific patient population treated with dabigatran etexilate compared to warfarin.
"Patient safety is our top priority and the company took appropriate action to stop the trial and inform regulatory authorities," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. "These findings do not affect the positive benefit-risk profile of PRADAXA 150mg twice daily when used as indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation."
PRADAXA has not been evaluated in the treatment of atrial fibrillation (AFib) caused by heart valve problems and cannot be recommended in these patients. The use of PRADAXA has not been evaluated in patients with bioprosthetic valves and use cannot be recommended for such patients.
"Boehringer Ingelheim is a science-based company that is proud to bring innovative products to patients and the medical community," commented Greg Behar , president and Chief Executive Officer, Boehringer Ingelheim Pharmaceuticals, Inc. "Our commitment to exploring innovation in areas with high unmet medical need remains unchanged."
The efficacy and safety of PRADAXA capsules was established in the RE-LY® trial, one of the largest stroke prevention clinical studies ever conducted in patients with non-valvular atrial fibrillation (NVAF). PRADAXA 150mg twice daily is the only treatment compared to warfarin to demonstrate superior reduction in ischemic and hemorrhagic stroke.
Nearly nine out of 10 strokes caused by AFib are ischemic strokes. In RE-LY, PRADAXA was proven to be 36 percent better than warfarin at reducing the risk of stroke in patients with NVAF. PRADAXA 150mg twice daily also showed a 59 percent lower rate of intracranial bleeding in the RE-LY trial, compared to warfarin.
Boehringer Ingelheim Pharmaceuticals, Inc.