EU committee recommends Boehringer's hypertension drug for approval

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The European Committee for Medicinal Products for Human Use has adopted a Positive Opinion for the approval of Boehringer Ingelheim’s single pill combination hypertension drug telmisartan/amlodipine (Twynsta).

If approved, the drug will be indicated in adults whose blood pressure is not adequately controlled on amlodipine and also indicated as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets. These patients can instead receive tablets of Twynsta containing the same component doses, according to the Ingelheim, Germany-based company.

Twynsta was approved by the FDA in 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.