Pharmaprojects R&D Pipeline News Feed
EU approvals for Daiichi Sankyo’s Sevikar
20th November 2008
Daiichi Sankyo has received European approvals for its combination product Sevikar, for the treatment of hypertensive patients inadequately controlled on monotherapy regimes. The fixed-dose combination of the calcium antagonist amlodipine and the A2-receptor antagonist olmesartan has been approved in Belgium, France, Germany, the Netherlands, Spain and the UK.
The EU approvals follow positive data from a Phase III trial in 1940 patients with mild-to-severe hypertension. In this trial, Sevikar showed better mean reductions in systolic and diastolic blood pressure than either agent alone, with efficacy in difficult-to-treat populations such as obesity and diabetes. The side effect profile was similar to that of monotherapy.
Olmesartan is launched in the US as Benicar. It is also launched in Europe as Olmetec, and as Olmetec Plus, a fixed-dose combination with the diuretic hydrochlorothiazide. It is patent-protected until 2017. Amlodipine is widely launched by Pfizer as Norvasc.
Currently more than half of European hypertension patients fail to meet their blood pressure targets on current therapies. Following the successful US launch of Azor in 2007, the European approvals for Sevikar now offer an alternative to patients with inadequately controlled hypertension. Further approvals are expected in the near future, with launch expected by the end of the fiscal year.
