Exforge Receives US Regulatory Approval as for Patients with High Blood Pressure
Exforge offers in one tablet the complementary actions of valsartan and amlodipine besylate, two of the most prescribed branded antihypertensive medicines
EAST HANOVER, N.J., December 22, 2006 -- Novartis announced today the US regulatory approval of Exforge as a new treatment option for patients with high blood pressure. Exforge combines in one tablet the two most commonly prescribed hypertension medicines in their categories -- Diovan (valsartan) and Norvasc (amlodipine besylate).
The US Food and Drug Administration (FDA) issued this tentative approval because Exforge has met all the required standards for safety, efficacy and manufacturing quality. Exforge is expected to be available to patients in the US in late September 2007, pending the expiration of market exclusivity and patent protection for amlodipine besylate.
In an extensive clinical program involving over 5,000 patients, Exforge helped up to nine out of 10 patients reach their treatment goal (diastolic blood pressure under 90 mmHg or more than a 10 mmHg reduction in diastolic blood pressure from baseline).
"The combination of these two well-known and powerful antihypertensive medications in one tablet will now give patients additional blood pressure control with favorable tolerability," said Bertram Pitt, MD, FACC, Professor of Medicine Emeritus at the University of Michigan School of Medicine Division of Cardiology in Ann Arbor, Michigan, USA.
The need for new antihypertensive medicines is urgent, as seven out of 10 patients are not at their target blood pressure goal. High blood pressure is a leading risk factor for cardiovascular disease, which is the worldâ€™s leading cause of death.
Exforge is appropriate for patients whose blood pressure is not adequately controlled on any dihydropyridine calcium channel blocker (CCB) or angiotensin receptor blocker (ARB). Also, it is appropriate for patients who experience dose-limiting side effects on either component, such as amlodipine-induced edema, dizziness and flushing.
Diovan blocks angiotensin II, a hormone that causes blood vessels to tighten and narrow, while amlodipine blocks the entrance of calcium into the blood vessel walls. Both allow blood vessels to relax so blood can flow more easily. Exforge also provides the convenience of a single once-daily tablet, which could reduce the overall number of pills a patient may need to take.
"Most patients need two or more medicines to control their blood pressure and achieve guideline targets," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Exforge promises to be an attractive therapy option because it brings together two of the most powerful mechanisms of action in a single pill."
In November, Exforge was granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), the regulatory agency that reviews European Union submissions for new medicines. Novartis expects to receive approval from the European Commission and to make Exforge available in the EU during the first half of 2007.
Posted: December 2006