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. Yype 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 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 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.”
Earlier this week, the US Food and Drug 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 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
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.