Novartis announced that the European Commission has granted approval for Exforge as a new and highly effective single-pill treatment for patients with high blood pressure.
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.
Exforge will be launched shortly in Germany followed by launches in most other European Union countries throughout the year, pending expiration of the patent protection for Norvasc. The EU decision, which applies in all 27 EU member states plus Iceland and Norway, follows recent tentative approval in the US and approval in Switzerland.
"High blood pressure is a major health concern. If left uncontrolled, it can lead to heart attacks, strokes, heart and kidney failure and premature death," said Prof. Rainer Düsing, internist at the Medizinische Universitäts-Poliklinik at the University of Bonn in Germany. "The combination of these two well-known and powerful anti hypertensive medications in one tablet will help patients reach and maintain their blood pressure goal with favourable tolerability."
Clinical trials involving over 5,000 patients demonstrated that Exforge helped up to nine out of 10 patients to reach their blood pressure goal (i.e. diastolic blood pressure under 90 mmHg or a more than 10 mmHg reduction from baseline). 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 highly efficacious and well tolerated with an improved side effect profile over amlodipine alone. In particular, Exforge has demonstrated a lower incidence of peripheral edema (or swelling) compared to amlodipine monotherapy.
"Exforge promises to be an attractive therapy option for patients because it brings together two of the most powerful mechanisms of action in one pill," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Delivering two agents in a single pill is associated with better compliance. Research has shown that improving compliance in patients being treated for high blood pressure leads to a reduction in medical costs, a reduced risk of hospitalisation and reduced use of outpatient resources."