For medical media, outside the US only
Closely following FDA approval, Micardis® is now indicated by the European Commission for the reduction of CV morbidity in patients with manifest atherothrombotic CV disease or type 2 diabetes with documented target organ damage.
Ingelheim/Germany, 26 November 2009 - Boehringer Ingelheim announced today 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.1 The results also demonstrated that Micardis>sup>® is better tolerated than the previous gold standard ramipril and is associated with higher treatment adherence.1-2
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.
Notes to 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 (for more information please visit www.news-landmarktrials.com).
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 European Heart Network – CVD Statistics. http://www.ehnheart.org/content/sectionintro.asp?level0=1457 Accessed October 2009.
5 British Heart Foundation Statistics Website http://www.heartstats.org/datapage.asp?id=754 Accessed October 2009.
6 J Mackay, G Mensah, Atlas of Heart Disease and Stroke. 2004 World Health Organization. Geneva.