New Antihypertensive Combo Exforge Gets U.S. Approval

Novartis said last Friday its Exforge antihypertensive medication had received approval from the U.S. Food and Drug Administration (FDA). Exforge combines valsartan and amlodipine besylate in one pill. “Exforge is expected to be available to patients in the U.S. in September 2007. Novartis announced 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).

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 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 world’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."

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