Boehringer Ingelheim has reported that the European Commission has approved Micardis (telmisartan) for the reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease or type 2 diabetes mellitus with documented target organ damage.
Micardis is the first treatment in its class to be approved for this indication. Micardis has also received approval for CV protection in Bolivia, Canada, Chile, Mexico, Paraguay, Philippines, Thailand and Uruguay. Its safety profile is similar to that of placebo.
The EMEA approval is the second major milestone for Micardis in cardiovascular protection.
The European Commission approval is based upon a review of clinical trial results, including the on target trial involving 25,620 patients and confirmed Micardis as the only treatment option in its class with proven cardiovascular protective effects in patients with high CV risk. The results also demonstrated that Micardis is better tolerated than the previous gold standard ramipril and is associated with higher treatment adherence.