Boehringer Ingelheim GmbH
Corporate Division Communications
Dr Reinhard Malin
Micardis® is now indicated for cardiovascular (CV) risk reduction in patients with intolerance to angiotensin-converting enzyme (ACE) inhibitors.Boehringer Ingelheim`s Micardis® (telmisartan) is the ONLY treatment in its class approved by the U.S. Food and Drug Administration (FDA) in patients at high CV risk who are unable to take ACE inhibitors
Micardis® is the first indicated treatment option in its class to prevent serious CV events in patients at high CV risk who are unable to take ACE inhibitors
This new indication is based on The ONTARGET Trial results which showed that Micardis® may prevent one in five serious CV events or death from cardiac causes.
For medical media, outside the US only
Ingelheim, Germany, 19 October 2009 - Boehringer Ingelheim announced today 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.
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.
Notes to the Editors
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA.
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.
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.
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1 The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Eng J Med.2008;358:1547-1559.
2 The TRANSCEND Investigators 2008. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomized controlled trial. The Lancet 2008;372:1174-1183.
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 European Heart Network – CVD Statistics. http://www.ehnheart.org/content/sectionintro.asp?level0=1457 Accessed October 2009.
7 British Heart Foundation Statistics Website