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.