Boehringer Ingelheim announces European CHMP Positive Opinion for TWYNSTA

Boehringer IngelheimJul 26 2010

Boehringer Ingelheim announced today 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.

“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.”

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.

"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^®):

• 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 (<130/80 mmHg according to the AHA criteria)

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

• the single pill combination of telmisartan and amlodipine (TWYNSTA^®) reduces 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.

Hypertension is a major CV risk factor and is responsible for more deaths than other factors, such as high cholesterol, diabetes or smoking. Study results show that even a 2 mmHg reduction in systolic blood pressure decreases the risk of severe cardiovascular events like heart attacks and strokes by 7-10%.

"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. 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.

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.