Boehringer Ingelheim's Pradaxa Available in U.S. Pharmacies Starting Wednesday, November 3 New oral anticoagulant for patients with atrial fibrillation has no required blood monitoring or related dose adjustments

RIDGEFIELD, Conn., Nov. 1, 2010 /PRNewswire/ -- 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.(1)  

"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, (1) it demonstrated benefits over warfarin, the current standard of care, including a significant reduction in the risk of stroke and systemic embolism. (1)  

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,(1) 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. (1)  A 75mg twice daily dose of PRADAXA also is approved for the small subset of patients who have severe renal impairment. (1)  

About Atrial Fibrillation and Stroke

Atrial fibrillation (AFib), characterized by an irregular heartbeat,(2) can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(2) An estimated 2.3 million Americans are living with AFib, (3) and the prevalence is expected to increase to 5.6 million by 2050.(3) A large managed care database study showed that non-valvular atrial fibrillation represents approximately 95 percent of all atrial fibrillation cases in the U.S. (3)  Atrial fibrillation increases the risk of stroke nearly five times (4)and is associated with up to 15 percent of all strokes in the U.S. (4) Strokes associated with AFib can be about twice as likely to be fatal (5) or severely disabling as non-AFib strokes.(6) Atrial fibrillation imposes a substantial economic burden to the healthcare system,(7) specifically the high costs associated with stroke.(8)  

About Pradaxa® (dabigatran etexilate) Capsules

Indications and Usage

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.

WARNINGS AND PRECAUTIONS

Risk of Bleeding

PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Risk factors for bleeding include:

- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).

-Labor and delivery

Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.

Temporary Discontinuation of PRADAXA

Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke.  Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.

Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure

The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other P-gp inhibitors.

ADVERSE REACTIONS

In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal events. PRADAXA 150 mg resulted in a higher rate of major gastrointestinal (GI) bleeds and any GI bleeds compared to warfarin. In patients greater than or equal to 75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions.  These were commonly dyspepsia (including abdominal pain, upper abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, gastritis, and GI ulcer).  Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.

Other Measures Evaluated

The risk of myocardial infarction was numerically greater in patients who received PRADAXA 150 mg than in those who received warfarin.  

For full PRADAXA prescribing information, please visit www.pradaxa.com or contact Boehringer Ingelheim's Drug Information Unit at 1-800-542-6257.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

(1) Pradaxa Prescribing Information

(2) NHLBI website. "What is AFib?" Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html. Accessed on: August 2, 2010.

(3) Go, Alan S., and Elaine M. Hylek et al. Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management and Stroke Prevention: the ATRIA Study. JAMA. 2002; 285:2370-2375.

(4)  Wolf P, et al. Atrial Fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991; 22:983-988.

(5) Lin HJ, et al. "Stroke Prevention in Atrial Fibrillation: The Framingham Study." Stroke. 1996; 27:1760-1764.

(6) Dulli D, et al. "Atrial Fibrillation is Associated with Severe Ischemic Stroke." Neuroepidemiology. 2003; 22:118-123.

(7) Coyne, K.S., et al. "Assessing the Direct Costs of Treating Nonvalvular Atrial Fibrillation in the United States." Value in Health.  2006; 9:348-356.

(8) Harley C., et al. Direct Costs And Health Care Utilization Associated With Stroke in the Presence of Atrial Fibrillation in the United States. ASAIS Conference, Feb. 2009.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.



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