Exforge combines in one tablet the power of the two most commonly prescribed branded hypertension medicines, Diovan and Norvasc. Exforge is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled by amlodipine or valsartan alone.
Novartis said the advantage of the treatment would be to improving compliance in patients leading to a reduction in medical costs and a reduced risk of hospitalization.
Exforge will be launched shortly pending expiration of the patent protection for Norvasc. The EU decision follows recent tentative approval in the US and approval in Switzerland.
The approval was based on trials that demonstrated that Exforge helped up to nine out of 10 patients to reach their blood pressure goal. Exforge has been shown in trials to deliver reductions in blood pressure of 36mmHg and up to 43mmHg in some patient populations. Overall, clinical trials have demonstrated that Exforge is efficacious and well tolerated with an improved side effect profile over amlodipine alone.