Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.(1) MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998. The FDA also approved a New Drug Application (NDA) for the combination agent Twynsta® (telmisartan/amlodipine) Tablets for the treatment of hypertension alone or in combination with other anti-hypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals.

"For those at high risk of cardiovascular events, it's important to find a treatment that helps reduce their risk. Further, two-thirds of people currently treated for hypertension are not at target blood pressure goals," said Dr. James Young, professor of medicine and executive dean of the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. "The newly approved use of telmisartan for cardiovascular risk reduction in high-risk patients who are unable to take an ACE inhibitor, and the availability of a telmisartan-amlodipine combination for hypertension, give patients and physicians much needed new treatment options for these chronic health problems."

Patients at high cardiovascular risk may have a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack or high-risk diabetes with evidence of end-organ damage. Some studies estimate that up to 20 percent of patients taking an ACE inhibitor experience side effects, usually cough, suggesting that some patients might be less likely to take this medication as prescribed. The approval of this additional indication for MICARDIS is based on the largest clinical trial program ever undertaken with an ARB, involving more than 31,000 high-risk cardiovascular patients with normal blood pressure or treated high blood pressure with a history of a broad range of cardiovascular diseases. The results of these studies supported that MICARDIS is more effective than placebo.

TWYNSTA combines the complementary blood pressure lowering effects of telmisartan, the active ingredient in MICARDIS, with the calcium channel blocker (CCB) amlodipine. TWYNSTA is not indicated for cardiovascular risk reduction. The new medicine will be available in pharmacies in November 2009 in the following strengths: 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg.

The FDA approval of TWYNSTA is based on the results of one placebo-controlled and two active-controlled trials involving a total of 3,505 patients with stage 1 or stage 2 hypertension. Results demonstrate that TWYNSTA was generally well-tolerated and provided significant blood pressure reductions in a variety of hypertensive patient populations compared with placebo or monotherapy.

"The approval of MICARDIS for cardiovascular risk reduction and TWYNSTA for hypertension demonstrates Boehringer Ingelheim's commitment to providing valuable options for the treatment of cardiovascular disease," said Dr. Thor Voigt, senior vice president, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "New options are important for the ultimate goal of ensuring patients receive appropriate treatment based on their individual needs."