Boehringer Ingelheim announced today 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.
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. 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.
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®:
- 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.
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.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%.
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