Boehringer Ingelheim’s Micardis (telmisartan) has been approved by the European Commission to reduce the risk of cardiovascular (CV) morbidity in high CV risk patients.
The granting of a marketing authorisation for Micardis to reduce CV morbidity in patients with manifest atherothrombotic CV disease or type 2 diabetes with documented target organ damage follows recent FDA approval in the US.
The drug is the only treatment in its class that demonstrates proven cardiovascular (CV) protection in patients at high CV risk and that has been approved in this indication.
The new indication is based on a review of clinical trials, including results from the ONTARGET trial, which showed that Micardis may prevent one in five serious CV events.
Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine of the University of Milan, Bicocca, Italy, said: “This new indication of telmisartan is a significant development for physicians and their at-risk patients. Prevention of CV events is vital as these are the primary causes of pathological death in Europe, due to lack of proper control of treatable risk factors and disease. The approval of telmisartan offers patients a well-tolerated treatment option which also provides CV protection.”
Professor Klaus Dugi, Corporate Vice President, Medical Affairs, Boehringer Ingelheim, commented: “These approvals clearly demonstrate the unique treatment option that Micardis now provides to both physicians and patients as the only medication in the ARB class to provide proven CV protection.”
Cardiovascular disease (CVD) is responsible for nearly one in three deaths worldwide and is the number one cause of death.