EMEA Issues Positive Opinion For Micardis

Boehringer Ingelheim has reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion for the approval of Micardis (telmisartan). It is for the reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus, with documented target organ damage.

Reportedly, CHMP opinion follows a review of clinical trial results including The ONTARGET Trial involving 25,620 patients. It confirmed Micardis as the only treatment option in its class with proven cardiovascular protective effects in patients with high CV risk.

The study results also demonstrated that Micardis is better tolerated than the previous gold standard ramipril and associated with higher treatment adherence.

The FDA has approved Micardis for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older, at high risk of developing major CV events who are unable to take ACE inhibitors.

Klaus Dugi, corporate vice president of medical affairs at Boehringer Ingelheim, said: We are delighted to receive this positive opinion from the CHMP. This is an important development that will help physicians ensure that patients receive appropriate treatment tailored to their individual needs. If approved, Micardis will offer a much needed alternative to ACE inhibitors in the treatment of patients with high CV risk.