FDA Approves Novartis's Exforge HCT to Lower Hypertension

The FDA gave its official thumbs-up to the antihypertensive polypill as initial therapy.

Exforge HCT contains the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide.

Although the FDA approved Exforge HCT for treatment of hypertension, it was not approved as initial therapy.

Instead, Exforge HCT can be substituted for patients already on all three individual drugs, used as add-on or switch therapy for patients not adequately controlled on any two of its component drug classes.

Novartis Pharmaceuticals Corp. of East Hanover, N.J., which is marketing the polypill, said it plans to offer Exforge HCT at the same price as its dual drug combination, Exforge (amlodipine and valsartan).

With a triple combination option, appropriate patients may experience a simpler routine of a convenient, once-daily pill to help them control their high blood pressureā€

— David A. Calhoun, MD, Professor of Medicine, Vascular Biology and Hypertension Program, University of Alabama at Birmingham

The US Food and Drug Administration (FDA) has approved Exforge HCT (amlodipine, valsartan, hydrochlorothiazide), the only blood pressure (BP) treatment to combine three medications in a single pill. Exforge HCT combines the number one prescribed calcium channel blocker, angiotensin receptor blocker, and diuretic in one pill, and is an important new option for patients who have tried taking dual combinations of these classes of blood pressure medications without success.

The FDA has approved Exforge HCT, which combines three blood pressure drugs -- amlodipine, valsartan, and hydrochlorothiazide -- into one pill.

Amlodipine is a calcium-channel blocker. Valsartan is an angiotensin-receptor blocker (ARB). Hydrochlorothiazide is a diuretic.

In June 2007, the FDA approved Exforge, which contains amlodipine and valsartan. The newly approved Exforge HCT adds hydrochlorothiazide.

The FDA approved Exforge HCT based on a clinical trial that included more than 2,000 patients, according to a news release from Novartis, the drug company that makes Exforge and Exforge HCT.

Novartis plans to offer Exforge and Exforge HCT at the same price in the U.S.