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.

Most Popular Now

Novo Nordisk announces plans to transform its appr…

Novo Nordisk announced plans to restructure its Research & Development (R&D) organisation to accelerate the expansion and diversification of its pipeline across serious c...

The Merck Accelerator Program 2019

The Merck Accelerator is looking for real partners so that you can work together in shaping the future. With programs in the headquarters in Germany, in China and the Sat...

World's largest Alzheimer's survey reveals most ad…

Amgen (NASDAQ:AMGN), Novartis and Banner Alzheimer's Institute (BAI), in association with Alzheimer's Disease International (ADI), announced results from the largest glob...

Imfinzi is the first immunotherapy to demonstrate …

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi durin...

Pre-clinical success for a universal flu vaccine o…

Researchers from the University of Oxford's Department of Zoology have demonstrated pre-clinical success for a universal flu vaccine in a new paper published in Nature Co...

Discovery could explain failed clinical trials for…

Researchers at King's College London have discovered a vicious feedback loop underlying brain degeneration in Alzheimer's disease which may explain why so many drug trial...

Global survey reveals that physicians need more in…

Results from a new global survey revealed that more than one-third (36%) of the 310 physicians surveyed do not think they have sufficient information required to make inf...

Aspirin found not to prolong healthy aging

Taking a low-dose aspirin daily does not prolong healthy living in older adults, according to findings from the ASPirin in Reducing Events in the Elderly (ASPREE) trial p...

The Lancet Respiratory Medicine publishes first Ph…

AstraZeneca today announced publication of results from the KRONOS Phase III trial which evaluated the efficacy and safety of triple combination therapy PT010 (budesonide...

In clinical trials, new antibody therapy controls …

Thanks to improvements in antiretroviral therapy, HIV is now a manageable condition. Yet even the best drugs do not entirely eliminate the virus, which latently lingers i...

FDA approves first treatment for advanced form of …

The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squam...

Clinical gene discovery program solves 30 medical …

A table in a recently published paper tells the story of 30 families who have, sometimes after years of searching, finally received an answer about the condition that has...