Boehringer Ingelheim receives European CHMP positive opinion for MICARDIS

Boehringer IngelheimOct 23 2009

Boehringer Ingelheim announced today 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) for the reduction of cardiovascular morbidity in patients with:

I. manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or

II. type 2 diabetes mellitus with documented target organ damage.

The CHMP opinion follows a review of clinical trial results including The ONTARGET 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.

Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer Ingelheim, commented, “We are delighted to receive this positive opinion from the CHMP. This is an important development that may 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.”

Earlier this week, the US Food and Drugs Administration (FDA) 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.

• Cardiovascular disease (CVD) is responsible for nearly one in three deaths worldwide and is the number one cause of death
• CVD causes nearly half of all deaths in Europe (48%) and in the EU (42%). About half of all deaths from CVD are from coronary heart disease and nearly one-third are from stroke
• 15 million people each year suffer strokes and 5 million are left permanently disabled