Pradaxa (dabigatran etexilate mesylate) U.S. Label Now Affirms Superior Reduction in Ischemic and Hemorrhagic Stroke Versus Warfarin in Patients with Non-Valvular Atrial Fibrillation

PRADAXA continues strong market performance 20 months after U.S. FDA approval

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the Pradaxa® (dabigatran etexilate mesylate) capsules prescribing information has been updated to affirm that "PRADAXA 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." The update to the "Clinical Studies" section is based on the results of the pivotal RE-LY® trial conducted in 18,000 patients with non-valvular atrial fibrillation (NVAF).

Clinical experience with PRADAXA continues to grow with more than 3.2 million prescriptions for PRADAXA 150mg and 75mg written for more than 600,000 NVAF patients in the U.S. since its approval in October 2010. Additionally, nearly 20,000 cardiologists and more than 90,000 other specialists or primary care physicians have prescribed PRADAXA through April 2012.

"PRADAXA is an important treatment option for many patients with NVAF as it is the only treatment compared to warfarin that provides a superior reduction in ischemic and hemorrhagic stroke, which is the main goal of anticoagulation treatment," said John Smith, MD, PhD, senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The inclusion of specific wording about the superiority of PRADAXA over warfarin in the prescribing information is important in defining the benefit it provides when physicians are considering treatment options for this patient population."

The launch of PRADAXA has been the most successful in Boehringer Ingelheim history and is among the pharmaceutical industry's top launches in the last decade. Formulary uptake has been strong for PRADAXA, which is now included on formularies that insure about 90 percent of covered lives in the U.S. PRADAXA also is on formulary with all 50 of the top heart and heart surgery hospitals in the U.S., as identified by U.S. News and World Report.

Boehringer Ingelheim remains focused on patient safety and is committed to further investigating PRADAXA through research such as the long-term safety study RELY-ABLE, which will be presented later this year. Additionally, Boehringer Ingelheim recently launched phase II of the GLORIA-AF patient registry, which is designed to better characterize the use of antithrombotic treatments to reduce the risk of stroke in patients with NVAF.

"Boehringer Ingelheim is committed to the AFib community and is continuing the work and support of educating healthcare professionals about the benefits and risks associated with PRADAXA," said Greg Behar, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "It is important for physicians and patients to discuss the important clinical benefit of superior stroke risk reduction with PRADAXA versus warfarin when considering treatment options."

In the RE-LY trial, PRADAXA 150mg twice daily was superior in reducing ischemic and hemorrhagic stroke compared to warfarin in patients with NVAF. The risk of major bleeds was similar with PRADAXA 150mg and warfarin across major subgroups with the exception of age, where there was a trend towards a higher incidence of major bleeding with PRADAXA for patients > 75 years of age. There were higher rates of major gastrointestinal (GI) bleeding and total GI bleeding with PRADAXA 150mg than warfarin. The incidence of intracranial bleeding, or bleeding inside the skull, was 59 percent lower with PRADAXA 150mg than warfarin in this patient population.

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