Major European Regulatory Milestone In Cardiovascular Protection For MICARDIS(R) (telmisartan)

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Heart Disease
Article Date: 30 Nov 2009 - 0:00 PST

email to a friend   printer friendly   view / write opinions

Boehringer Ingelheim announced 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. The results also demonstrated that MICARDIS® is better tolerated than the previous gold standard ramipril and is associated with higher treatment adherence.

- 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%). 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

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.

Source
Boehringer Ingelheim