FDA Approves MICARDIS(R) As The First Treatment In Its Class To Reduce The Risk Of Heart Attack, Stroke, Or Death From Cardiovascular Causes...

Main Category: Heart Disease
Also Included In: Cardiovascular / Cardiology;  Stroke;  Regulatory Affairs / Drug Approvals
Article Date: 21 Oct 2009 - 1:00 PDT

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Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved a new indication for MICARDIS® (telmisartan) 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. MICARDIS® is the first treatment in its class to be approved for this indication.

The FDA approval is based upon clinical trial results from 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 with this new indication for MICARDIS®, which will provide both physicians and their patients who are at risk of cardiovascular events with a much needed alternative to ACE inhibitors. Approximately one in four patients are unable to tolerate an ACE inhibitor. Now, these patients can be confident that with MICARDIS®, they have a proven, effective and well tolerated option to reduce their risk of severe CV events."

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) is currently reviewing a similar submission for MICARDIS® in Europe. The recommendation from the CHMP is expected in November.

- Cardiovascular disease (CVD) is responsible for nearly one in three deaths worldwide and is the number one cause of death

- Every year, nearly 900,000 Americans die from CVD. This is equivalent to around 2,300 deaths every day or two every minute

- 80 million Americans currently suffer from one or more forms of CVD - more than the total population of France

- 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.

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.

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Source
US Food and Drug Administration