The EU has granted approval for Boehringer Ingelheim's Micardis (telmisartan) to prevent morbidity in patients with cardiovascular disease, a leading cause of deaths in Europe.
The treatment is the first in its class to be approved for use in patients with a history of coronary heart disease, stroke or peripheral arterial disease, or type 2 diabetes mellitus with documented target organ damage.
The approval is the second major milestone for Micardis, which has been approved in the US to reduce the risk of myocardial infarction, stroke or death from cardiovascular diseases in patients aged 55 or older.
Boehringer Ingelheim corporate vice-president Professor Klaus Dugi said that these approvals demonstrate the unique treatment option that Micardis now provides.
"Micardis is important to physicians and patients as the only medication in the ARB class to provide proven CV protection," Dugi said.
EU approval was based on clinical trial results, including the ONTARGET trial which involved 25,620 patients and confirmed Micardis as having proven cardiovascular protective effects in patients with high CV risk as well as high tolerability.