European Medicines Agency approves TWYNSTA®

Boehringer IngelheimBoehringer Ingelheim announced that the European Commission confirmed the positive opinion of the European Medicines Agency (EMA) approving TWYNSTA®. TWYNSTA® is indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled on amlodipine or as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets containing the same component doses.

TWYNSTA® is a new highly effective and well tolerated single pill combination therapy of telmisartan, an angiotensin receptor blocker and amlodipine, a calcium channel blocker, for the treatment of hypertension. It delivers BP reductions of up to 50 mmHg and controls BP for the full 24 hours in up to 83% of patients.(1-4)

TWYNSTA consistently reduces blood pressure in a broad range of patients including those with mild, moderate and severe hypertension. In particular, it is effective in hypertensive patients with added risk such as those with obesity, metabolic syndrome and diabetes.

Both telmisartan and amlodipine have a proven evidence base in cardiovascular outcomes. TWYNSTA® combines telmisartan and amlodipine the two longest acting agents in each class.(1-4) Of the ARB class, only telmisartan is indicated to reduce CV morbidity (myocardial infarction [heart attack] and stroke) in a wide range of patients at risk of serious cardiac events.(5,12)

Professor Michael Böhm, Director and Chief of Department of Internal Medicine and Cardiology at the University of Saarland in Germany said, "For patients at higher risk of cardiovascular disease, that is patients with higher blood pressure, this combination will offer particular efficacy advantages over monotherapies, and possibly over other combination therapies. It is well tolerated and patients may experience less side effects when compared with amlodipine alone. Both factors are highly relevant to the treating physicians because they ensure patients are less likely to discontinue their treatment."

The approval of TWYNSTA® by the European Commission follows a review of three pivotal clinical trials. Results from these studies show that TWYNSTA®(2-4,13-15):

  • provided consistent and significantly greater blood pressure reduction compared to the respective monotherapies with the 40-80mg/5-10mg formulations
  • allowed 82.7% of patients to achieve their 24hr blood pressure goal (<130/80 mmHg according to the AHA criteria) with the 80mg/10mg formulation.

In addition, results from a recent double-blind, randomised, controlled trial in patients with severe hypertension (TEAMSTA severe HTN) showed that:

  • TWYNSTA® reduced systolic blood pressure by a mean of nearly 50 mmHg. This powerful reduction, observed in nearly half of patients, is among the highest blood pressure reduction achieved in antihypertensive trials.(1)

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, commented: "We are delighted to receive European approval of TWYNSTA®. The data show it is effective and well tolerated in a range of hypertensive patients including those with additional risk factors such as diabetes and obesity and we believe that it will provide an important treatment option for both physicians and patients to achieve good blood pressure control."

High blood pressure is the number one risk factor for CV disease and responsible for more deaths than any other single CV risk factor including high cholesterol, diabetes or smoking. 4 A large meta-analysis of 61 studies including about 1 million patients (12.7 million patient years) suggests that a reduction of 2 mmHg in systolic blood pressure decreases the risk of CV events such as myocardial infarction and stroke by 7-10%.(16)

TWYNSTA® was approved in the US in October 2009 and in Japan in July 2010. Boehringer Ingelheim is committed to make this valuable new therapeutic option available to patients and health care professionals as soon as possible.

TWYNSTA® is a once daily, single-pill combination of angiotensin II receptor (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine, for the treatment of hypertension.

On October 2009, the US Food and Drug Administration (FDA) approved TWYNSTA® (telmisartan plus amlodipine) for use in the treatment of hypertension alone, or with other antihypertensive agents, and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

The single pill combination of telmisartan and amlodipine is also approved as MICAMLO® in Japan.

About telmisartan (Micardis®/Kinzal®/Pritor®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and has been 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

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 HealthCare in Europe and GlaxoSmithKline in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark MICARDIS®, Bayer HealthCare 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® is also marketed by GlaxoSmithKline in selected markets.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.

1. Neutel JM, Mancia G, et al. Single-pill combination of telmisartan 80 mg/amlodipine 10 mg provides superior blood pressure reductions in patients with severe hypertension: TEAMSTA Severe HTN Study. Poster presentation at the European Society of Hypertension (ESH), June 2010.
2. White B et al. Effects of telmisartan and amlodioine in combination on amulatory blood pressure in stages 1 -2 hypertension Blood Pressure. epub Blood Pressure Monitoring 2010.
3. Littlejohn J, et al. Results of treatment with telmisartan-amlodipine in Hypertensive Patients. J Clinl Hypertens 2009;11:4:207-213.
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