Boehringer Ingelheim GmbH
Corporate Division Communications
Dr Reinhard Malin
55216 Ingelheim
Germany
Value through Innovation17 January 2013
19 October 2009
FDA approves Twynsta® (telmisartan plus amlodipine) a new single pill combination that delivers powerful and consistent blood pressure reductions throughout 24 hours
Twynsta® delivers very powerful blood pressure (BP) reductions of up to 40/29 mmHg1 and a 24-hour BP response rate of up to 98%2 for hypertensive patients at risk of cardiovascular (CV) events
Twynsta® combines the proven evidence base in CV outcomes of telmisartan and amlodipine3-9 in a convenient single pill
Twynsta® achieves superior BP reductions compared to amlodipine 10mg and is significantly better tolerated with 71% less peripheral oedema.10
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 Twynsta®, a new highly effective single pill combination therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]). Twynsta® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
This new combination benefits from the complementary modes of action of long-lasting angiotensin receptor- and calcium channel-blockade. This provides powerful efficacy in 24-hour BP reduction and control10-17 and combines it with the proven evidence base in cardiovascular (CV) outcomes3-9 of both telmisartan and amlodipine. Telmisartan is the only ARB with proven evidence to reduce CV death, myocardial infarction (heart attack) and stroke beyond the effect of BP reduction in a wide range of patients at risk of CV events.3-4 In the US, it is the only ARB indicated for CV risk reduction in patients who are unable to take ACE-inhibitors.18
Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine of the University of Milan, Bicocca, Italy said, In hypertensive patients, treatment tolerance and compliance are significant issues. The data for this combination of telmisartan and amlodipine show that it is effective and well tolerated in a range of more complex, difficult-to-treat patients as well as in those whose BP was previously not controlled on monotherapy. This combination provides a valuable and important new option for patients and physicians, particularly as it includes two components, telmisartan and amlodipine, each with clinically proven CV protection in patients at CV-risk.
The FDA approval of Twynsta® is based on the results of one placebo-controlled and two active-controlled trials involving a total of 3,505 patients with stage 1 or stage 2 hypertension.*20-21These trials demonstrated that Twynsta® provided powerful BP lowering that was sustained for at least 24-hours, and was also effective and well-tolerated in hypertensive patients at risk of CV events, including patients with Type 2 diabetes, elderly and obese patients.
Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer Ingelheim, commented, We are delighted with the approval of Twynsta® and believe that, with its excellent safety profile and demonstrated efficacy, Twynsta® will help physicians and patients to overcome common barriers to effective blood pressure control, such as treatment adherence.
Twynsta® will be available in the US from November 2009 in a flexible range of dosing regimens (40/5mg, 40/10mg, 80/5mg, 80/10mg) enabling physicians to tailor treatment to individual patient needs.
Twynsta® has recently also been submitted for approval in Europe and Japan, and is on schedule to be submitted in other countries around the world. Boehringer Ingelheim is committed to make this valuable new therapeutic option available to patients and health care providers as soon as possible after Marketing Authorisation approval is obtained.
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 U.S.A.
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 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 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.
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.
Related links
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References:
1 Data on file, Boehringer Ingelheim.
2 Littlejohn TW III et al. Telmisartan and amlodipine combination therapy is powerful at lowering 24-hour blood pressure: Findings of an ambulatory blood pressure monitoring substudy in hypertensive patients. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
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4 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.
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13 Littlejohn T, et al. Telmisartan in combination with amlodipine provides highly effective and well tolerated treatment option for hypertensive patients with diabetes: sub-analysis from a factorial design study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
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15 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in Black and Latin American hypertensive patients: finding of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
16 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in diabetic and obese hypertensive patients: findings of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
17 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in elderly hypertensive patients and those with elevated SBP: findings of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
18 MICARDIS (telmisartan) US Label / Summary of Product Characteristics
19 Seventh The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure http://www.nhlbi.nih.gov/guidelines/hypertension/jnc7full.htm, accessed on 16th October 2009
20 Neldem S, et al. Fixed-dose combination therapy with telmisartan and amlodipine 5 mg in non-responders to amlodipine 5 mg provides superior blood pressure reductions to, and is better tolerated than, amlodipine 10 mg. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
21 Neldam S, et al. Switch to a fixed-dose combination therapy with telmisartan and amlodipine provides significant blood pressure reduction and control in patients not adequately controlled with amlodipine 10 mg. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.
