FDA approves Micardis® (telmisartan) as the first treatment in its class

Boehringer IngelheimBoehringer 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.(1-2)

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 is 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(3)
  • Every year, nearly 900,000 Americans die from CVD. This is equivalent to around 2,300 deaths every day or two every minute(4)
  • 80 million Americans currently suffer from one or more forms of CVD4 more than the total population of France(5)
  • CVD causes nearly half of all deaths in Europe (48%) and in the EU (42%).(6) About half of all deaths from CVD are from coronary heart disease and nearly one-third are from stroke.(7)

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.

About telmisartan (Micardis®/Kinzal®/Pritor®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and was investigated in the most ambitious and far-reaching research programme conducted with an ARB. In the clinical trial programmes ONTARGET™, PROTECTION™ and PRoFESS®, over 58,000 patients were enrolled to investigate the efficacy and cardiovascular protective effects of telmisartan.

Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis® and MicardisPLUS® (combination with hydrochlorothiazide) the company markets telmisartan in 84 countries around the world, including the USA, Japan and European countries. Telmisartan is marketed in cooperation with Astellas Pharma Inc. in Japan, Bayer Schering Pharma in Europe and GlaxoSmithKline in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis®, Bayer Schering Pharma promotes telmisartan under the brand names Kinzalmono®, Kinzalkomb® (combination with hydrochlorothiazide), and Pritor® and PritorPlus® (combination with hydrochlorothiazide) in markets across Europe. Pritor® and PritorPlus® are also marketed by GlaxoSmithKline in selected markets.

The sponsor of the ONTARGET™ Trial Programme is Boehringer Ingelheim; co-funders in selected countries are Bayer Schering Pharma and GlaxoSmithKline.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

1. The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Eng J Med. Published online 31 March 2008.
2. The TRANSCEND Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomized controlled trial. Lancet. Published online 31 August 2008.
3. World Health Organization, Fact Sheet 317: Cardiovascular Diseases September 2009. http://www.who.int/mediacentre/factsheets/fs317/en/index.html. Accessed October 2009.
4. American Heart Association, Cardiovascular Disease Statistics. http://www.americanheart.org/presenter.jhtml?identifier=4478. Accessed October 2009.
5. Wikipedia, Demographics of France. http://en.wikipedia.org/wiki/Demographics_of_France. Accessed October 2009.
6. World Health Report 2004 Changing History. http://who.int.wrh/2004/en/. Accessed June 2009.
7. Integrated Management of Cardiovascular Risk. Report of a WHO Meeting, Geneva, July 2002.

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