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news.Boehringer Ingelheim has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for the approval of Twynsta.
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Twynsta is expected to 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.
Boehringer Ingelheim claimed that Twynsta 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.
Boehringer Ingelheim said that, if approved, the new single pill combination (Twynsta) is expected to provide patients and prescribers with a combination of Telmisartan, an angiotensin receptor blocker (ARB), and amlodipine, a calcium-channel blocker (CCB), for the treatment of hypertension.
The CHMP opinion follows a review of three pivotal clinical trials. Results from these studies show that the single pill combination of TTelmisartan and amlodipine (Twynsta) provides blood pressure reduction compared to the respective monotherapies
Additionally, 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 50mmHg.
The single pill combination of Telmisartan and amlodipine Twynsta is found to be 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 in clinical trials.
Boehringer Ingelheim stated that Twynsta was approved by the FDA on October 19, 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.
Klaus Dugi, corporate senior vice president medicine of Boehringer Ingelheim, said: “We are pleased that, following a final decision from the European Medicines Agency, Twynsta will provide physicians with a new treatment option for hypertensive patients.
“The long duration of action of both components of Twynsta make it a meaningful option in the treatment of hypertension where blood pressure control is not achieved with monotherapy alone.”