Boehringer Ingelheim announced that the European Committee for Medicinal Products for Human Use (CHMP) adopted a Positive Opinion for the approval of TWYNSTA®. It will be indicated in adults whose blood pressure is not adequately controlled on amlodipine and is also indicated as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of TWYNSTA containing the same component doses.

Once approved, the new single pill combination (TWYNSTA®) will provide patients and prescribers with a highly effective combination of telmisartan, an angiotensin receptor blocker (ARB), and amlodipine, a calcium-channel blocker (CCB), for the treatment of hypertension. It will reduce blood pressure effectively and safely in a broad range of patient groups including those with mild, moderate and severe hypertension as well as hypertensive patients at high cardiovascular risk, such as those with diabetes or metabolic syndrome.1-8

"We are pleased that, following a final decision from the European Medicines Agency, TWYNSTA® will provide physicians with a valuable new treatment option for hypertensive patients," commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The long duration of action of both components of TWYNSTA® make it a unique and very meaningful option in the treatment of hypertension where blood pressure control is not achieved with monotherapy alone."

The CHMP opinion follows a review of three pivotal clinical trials. Results from these studies show that the single pill combination of telmisartan and amlodipine (TWYNSTA®): 2-7

- in the 40-80mg/5-10mg formulation provides significantly greater blood pressure reduction compared to the respective monotherapies

- with the 80mg/10mg formulation, 82.7% of patients achieved their 24hr blood pressure goal ( "We know that at least half of the patients miss at least one dose a month of their medication. We know that a third miss at least two doses a month. If we give them more tablets, they are more likely to miss more doses and that may mean that they are at much higher risk of stroke or of a heart attack," said Prof Thomas Unger, from the Charité Hospital in Berlin. "So, I would consider recommending this true once daily single-pill combination of telmisartan and amlodipine to a patient. I genuinely think that by improving a patient's blood pressure control, without having to increase the number of tablets, I could improve the likelihood of reducing his cardiovascular risk avoiding a stroke."

The single pill combination of telmisartan and amlodipine TWYNSTA® demonstrated in clinical trials that it is effective and well-tolerated in a range of more complex at-risk patients, as well as in those whose blood pressure was previously not controlled on monotherapy. 1-8 It contains telmisartan, the only ARB clinically proven in reducing the risk of cardiovascular death, myocardial infarction, stroke, and hospitalisation for congestive heart failure in a broad cross-section of high-risk cardiovascular patients.9,10

Once approved, the single pill combination of telmisartan and amlodipine (TWYNSTA®) will be available in a flexible range of dosing regimens enabling physicians to tailor treatment to individual patient needs.

TWYNSTA® was approved by the FDA on 19 October 2009 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.

References

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.

4. Neldam S, Lang M, 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 associated with less peripheral oedema than, amlodipine 10 mg. Poster presentation at the American Society of Hypertension (ASH), May 2009.

5. Neldam S, Edwards C, et al. Investigators. 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. Poster presentation at the American Society of Hypertension (ASH), May 2009.

6. Neldam S, Lang M, et al. Long-term safety and efficacy of single-pill combinations of telmisartan 40 - 80 mg plus amlodipine 5 mg in patients initially not controlled on amlodipine 5 mg: open-label follow-up of the TEAMSTA-5 study (TEAMSTA-5 follow-up). Poster presentation at the European Society of Hypertension (ESH), June 2010.

7. Neldam S, Edwards C, et al. Long-term safety and efficacy of single-pill combinations of telmisartan 40 - 80 mg plus amlodipine 10 mg in patients not initially controlled on amlodipine 10 mg: open-label follow-up of TEAMSTA-10 study (TEAMSTA-10 follow-up). Poster presentation at the European Society of Hypertension (ESH), June 2010.

8. Littlejohn T, Ruilope LM, et al. Telmisartan in combination with amlodipine provides a highly effective and well-tolerated treatment option for hypertensive patients with diabetes: sub-analysis from a factorial design study. Poster presentation at the European Society of Hypertension (ESH), June 2009.

9. The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. New England Journal of Medicine 2008;358(15):1547-59.

10. MICARDIS SmPC 2010.

11. Lopez AD, et al. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet 2006;367:1747-1757.

12. Lewington S, et al. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-13.

Source:
Boehringer Ingelheim

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