Major European Regulatory Milestone in Cardiovascular Protection for MICARDIS® (telmisartan): Now Approved by the European Commission to Reduce the Risk of Cardiovascular (CV) Morbidity in High CV Risk Patients

Closely following FDA approval, MICARDIS® is now indicated by the European Commission for the reduction of CV morbidity in patients with manifest atherothrombotic CV disease or type 2 diabetes with documented target organ damage. MICARDIS® (telmisartan) is the ONLY treatment in its class with this indication, demonstrating proven cardiovascular (CV) protection in patients at high CV risk This 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 events1 Patients at-risk of heart attack and stroke can now benefit from this new indication.

Boehringer Ingelheim announced today that the European Commission has approved 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.

MICARDIS® is the first treatment in its class to be approved for this indication. The EMEA approval is the second major milestone for MICARDIS® in cardiovascular protection. It follows the approval by the US FDA 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.

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, “We are delighted to receive this indication for MICARDIS® from the European Commission which closely follows the approval granted by the FDA in the US. 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.”

The European Commission approval is based upon 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.1 The results also demonstrated that MICARDIS® is better tolerated than the previous gold standard ramipril and is associated with higher treatment adherence.1-2
Cardiovascular disease (CVD) is responsible for nearly one in three deaths worldwide and is the number one cause of death3
CVD causes nearly half of all deaths in Europe (48%).4 About half of all deaths from CVD are from coronary heart disease and nearly one-third are from stroke5
15 million people each year suffer strokes and 5 million are left permanently disabled6

MICARDIS® has also received approval for CV protection in Bolivia, Canada, Chile, Mexico, Paraguay, Philippines, Thailand and Uruguay.

MICARDIS® is one of the most studied antihypertensives in clinical trials and is widely used with over five million patient years since its approval. Its safety profile is similar to that of placebo.

To view ‘Notes to Editors’ and References, please click on the link below:

http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=7135

CONTACTS :

Boehringer Ingelheim GmbH
Dr. Reinhard Malin, + 49 – 6132 – 77 90815
Corporate Division Communications
Fax: + 49 – 6132 – 72 6601
reinhard.malin {at} boehringer-ingelheim(.)com