Boehringer Ingelheim Pharmaceutical in Ridgefield has gained approval for new heart disease-related tablets.
U.S. Food and Drug Administration approved the supplemental new drug application, Micardis Tablets 80 mg, an angiotensin II receptor blocker or ARB.
The tablets are designed to reduce the risk of myocardial infarction, stroke or death from cardiovascular causes in those over 55.
“For those at high risk of cardiovascular events, it’s important to find a treatment that helps reduce their risk,” said Dr. James Young, professor of medicine and executive dean of the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. “Further, two-thirds of people currently treated for hypertension are not at target blood pressure goals.”
Young said Micardis is the most-studied ARB in this high-risk patient population.
The drug first bacame available to treat hypertension in its initial version in 1998.
The FDA also approved the new drug application for the combination agent Twynsta Tablets for the treatment of hypertension alone or in combination with other anti-hypertensive agents.
“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,” said Young.
Dr. Thor Voigt, senior vice president of medicine and drug regulatory affairs at Boehringer Ingelheim said new options are important for the ultimate goal of ensuring patients receive appropriate treatment based on their individual needs.
“The approval of Micardis for cardiovascular risk reduction and Twynsta for hypertension demonstrates our commitment to providing valuable options for the treatment of cardiovascular disease.”
