Novartis announced today a positive opinion supporting European Union approval of Exforge? (valsartan/ amlodipine besylate) as a new treatment option for patients with high blood pressure.
The Committee for Medicinal Products for Human Use (CHMP) issued the positive opinion for this investigational compound based on data showing efficacy and tolerability of Exforge for the treatment of high blood pressure in a clinical trial program involving 5,000 patients.
Exforge is the first high blood pressure medication to combine the two most commonly prescribed high blood pressure medicines in their classes – the angiotensin receptor blocker (ARB) valsartan (Diovan?) and the calcium channel blocker (CCB) amlodipine besylate (Norvasc?).
The European Commission generally follows the CHMP’s recommendations and is expected to issue a decision within three months. Novartis plans to make Exforge available to patients in Europe in the April 2007. Exforge has also been submitted for US approval earlier this year, and a decision by the US Food and Drug Administration (FDA) is anticipated in the coming months.
“Exforge offers a potential solution to many patients with high blood pressure who currently need two or more medicines to control their illness. This positive opinion for Exforge is highly encouraging since this medicine has been shown to get patients to blood pressure goal with an excellent efficacy and tolerability profile and a reduced pill burden,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
High blood pressure – and its consequences – is the world’s No. 1 killer, estimated by the American Heart Association to affect one in four adults – around one billion people globally. Despite extensive use of current therapies, about 70% of all people with high blood pressure do not reach target blood pressure levels. Many people require two or more medicines to control their blood pressure.
More than 80% of Exforge patients studied reached their recommended blood pressure goals, with reductions in blood pressure of up to 43 mmHg in some groups, according to Phase III data[1] presented at the American Society of Hypertension in May 2006. Exforge also showed a lower incidence of peripheral edema (swelling of the ankles) compared to those taking amlodipine alone.