Novartis has received US approval for Exforge, a combination of two of the world’s most-prescribed anti-hypertensives, which analysts believe will be a blockbuster.
Exforge combines Novartis’ own angiotensin II receptor blocker Diovan (valsartan) with Pfizer’s calcium channel blocker Norvasc (amlodipine) in a single, once-daily tablet and has been approved by the US Food and Drug Administration for use in high blood pressure patients who have not been controlled through the use of angiotensin receptor or calcium channel blockers, and for patients who have experienced dose-limiting side effects on either type of medicine. These include amlodipine-induced edema, dizziness or flushing.
Novartis said that the go-ahead, which follows an approvable letter in December 2006 (pending the expiry of the US patent on Norvasc), was received on the basis of “an extensive clinical programme involving more than 5,000 patients” and in data from two placebo-controlled trials, Exforge helped up to nine out of ten patients reach their treatment goal of diastolic blood pressure under 90mmHg, or more than a 10mmHg reduction from baseline levels. In two other studies, Exforge demonstrated superior blood pressure lowering efficacy in patients uncontrolled when taking either valsartan or amlodipine alone.
"High blood pressure continues to be a major public health issue in the USA and many patients will require multiple medications to achieve blood pressure control," said Bertram Pitt at the University of Michigan School of Medicine "This new treatment (which was approved in Europe in January) offers great efficacy and improved convenience with a single tablet." Novartis noted that high blood pressure affects at least 29% of all adults in the USA and one billion people suffer from the condition globally, which is expected to rise to about 1.6 billion by 2025.