European Commission clears Boehringer Ingelheim's blood pressure combo drug Twynsta

Independent German drugmaker Boehringer Ingelheim announced yesterday that the European Commission confirmed the positive opinion of the European Medicines Agency (EMEA) on its combination blood pressure drug, approving Twynsta (telmisartan and amlodipine). The decision follows an approval recommendation for the EMEA’s Committee for Medicinal Products for Human Use (CHMP) earlier this year (The Pharma Letter July 26). The drug has also been cleared by the US Food and Drug Administration (TPL October 20, 2009).

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. It 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, according to the company

Michael Bohm, professor and director and chief of the 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 fewer 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.”