Boehringer Ingelheim Pharmaceuticals, Inc. today announced that its new oral anticoagulant, Pradaxa® (dabigatran etexilate mesylate) 150mg capsules, will be available starting Wednesday by prescription in pharmacies across the United States, including CVS/pharmacy, Rite Aid, Walmart, Target, Kmart® and The Kroger Co. In addition, leading independents under the Health Mart®, Good Neighbor Pharmacy® and Medicine Shoppe® banners will be stocked. The 75mg dose of PRADAXA will be available in pharmacies in the coming weeks. The U.S. Food and Drug Administration (FDA) approved PRADAXA on October 19, 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
"The rapid availability of PRADAXA following FDA approval is a reflection of Boehringer Ingelheim's commitment to improving care for patients and their families," said Wa'el Hashad, vice president, cardiovascular and metabolic disorders marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We've already received an overwhelmingly positive response from the atrial fibrillation community and we're pleased that this innovative new treatment will soon be available for patients with the condition who are at increased risk for stroke."
The wholesale acquisition price for both doses of PRADAXA will be $6.75 a day for two capsules. PRADAXA has been in development for nearly 15 years and in the 18,113 patient, Phase III RE-LY® trial, it demonstrated benefits over warfarin, the current standard of care, including a significant reduction in the risk of stroke and systemic embolism.
At Boehringer Ingelheim, the health of our patients is our first priority and we work diligently to ensure our medications are accessible and affordable for all patients. We are in active discussions with various insurance companies about formulary coverage and anticipate PRADAXA will be reimbursed at a co-pay level similar to other preferred branded products. Programs that offer financial assistance to those who may otherwise be unable to afford medication also are available through the BI CARES Foundation.
"Treatment with PRADAXA does not require routine blood monitoring or related dose adjustments. In addition, there are no recommended dietary restrictions," said Christopher Corsico, M.D., MPH, medical director, Boehringer Ingelheim Pharmaceuticals, Inc. "PRADAXA has the potential to significantly impact the treatment paradigm for patients with non-valvular atrial fibrillation. We are working with insurers to make PRADAXA as affordable and accessible as possible."
PRADAXA 150mg taken twice daily has been shown to significantly reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin, the current standard of care for patients with non-valvular atrial fibrillation. PRADAXA 150mg taken twice daily has been shown to significantly reduce both ischemic strokes (caused by blood clots) and hemorrhagic strokes (caused by bleeding) compared to warfarin. A 75mg twice daily dose of PRADAXA also is approved for the small subset of patients who have severe renal impairment.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.