The US approval of Exforge was supported by a clinical program involving more than 5,000 patients. The FDA had tentatively approved Exforge in December 2006 and has now granted final approval.
Exforge offers two of the most prescribed high blood pressure medicines in a single-tablet form. It combines the active ingredients of an angiotensin receptor blocker – Diovan (valsartan) – and a calcium channel blocker – Norvasc (amlodipine).
In two placebo-controlled trials, Exforge helped up to nine out of ten patients reach their treatment goal of diastolic blood pressure under 90 mmHg, or more than a 10 mmHg reduction in diastolic blood pressure from baseline levels.
Exforge was approved in January 2007 in the European Union and has already been made available in nine EU countries, including Germany and the UK, with further launches planned.