Technology | October 19, 2009

FDA Approves Micardis to Help Reduce MI, Stroke, Death

October 19, 2009 – Boehringer Ingelheim Pharmaceuticals Inc. said today the 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 age 55 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 James Young, M.D., 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.(2, 3) 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.(2, 4) The results of these studies supported that MICARDIS is more effective than placebo.(1) 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.(5) Telmisartan is marketed in the U.S. as MICARDIS Tablets by Boehringer Ingelheim Pharmaceuticals Inc. It is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. MICARDIS is also indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors. Because studies with telmisartan did not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared, consider using the ACE inhibitor first. Telmisartan/amlodipine is marketed in the U.S. as TWYNSTA tablets by Boehringer Ingelheim. It is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. For more information: References: 1. MICARDIS PI. Boehringer Ingelheim Pharmaceuticals. Inc. Ridgefield, Conn. 2. “The Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomized controlled trial.” Lancet, 2008; doi:10.1016/S0140-6736(08)61242-8. 3. Wogen J., Kreilick C., Livornese R., Yokoyama K., Frech F. “Patient adherence with amlodipine, lisinopril or valsartan therapy in a usual-care setting.” JMCP, 2003; 9: 424-429. 4. “The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events.” New England Journal of Medicine, 2008; 358:1,547-59. 5. TWYNSTA PI. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Conn. 6. American Heart Association. High Blood Pressure Statistics. Accessed Sept. 15, 2009. 7. American Heart Association. What is High Blood Pressure? Accessed May 28, 2009. 8. American Heart Association. High Blood Pressure. Accessed May 28, 2009. 9. American Heart Association. Heart Disease and Stroke Statistics - 2009 Update. Accessed May 28, 2009. 10. U.S. Centers for Disease Control and Prevention. Heart Disease and Stroke Prevention.

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