NOVARTIS WINS TENTATIVE APPROVAL FOR BLOOD PRESSURE COMBINATION PILL

The FDA has tentatively approved Novartis' Exforge as a new treatment option for patients with high blood pressure, the company announced. Exforge combines in one tablet the two most commonly prescribed hypertension medicines in their categories -- Diovan (valsartan) and Norvasc (amlodipine besylate).

The FDA issued the tentative approval because Exforge has met all the required standards for safety, efficacy and manufacturing quality, according to Novartis. Exforge is expected to be available to patients in the U.S. in late September, pending the expiration of market exclusivity and patent protection for amlodipine besylate.

In an extensive clinical program involving more than 5,000 patients, Exforge helped up to nine out of 10 patients reach their treatment goal (diastolic blood pressure of less than 90 mmHg or a greater than a 10 mmHg reduction in diastolic blood pressure from baseline).

Exforge is appropriate for patients whose blood pressure is not adequately controlled on any dihydropyridine calcium channel blocker or angiotensin receptor blocker, Novartis said. 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, Novartis said.