Novartis single-pill therapy for hypertension gains approval

The new hypertension drug indications permit a single pill, first-line treatment. Source: Reason Magazine

The FDA has approved two single-pill combination medications, Diovan HCT and Exforge, from Novartis Pharmaceuticals as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. 

The two drugs, Diovan HCT (valsartan and hydrochlorothiazide) and Exforge (amlodipine and valsartan) were not approved to treat or prevent stroke, MI, heart failure, kidney failure or eye problems.

Diovan HCT combines in one tablet Diovan (valsartan), a high-blood pressure drug, and hydrochlorothiazide, a high blood pressure treatment from the diuretics drug class. Exforge is the first treatment to combine Diovan (an angiotensin receptor blocker) and the calcium channel blocker amlodipine besylate, two high-blood pressure medications into a once-daily single tablet, according to the East Hanover, N.J.-based company.

Using single-pill combination medications as a first-line therapy will reduce the added steps of starting on a single medication, increasing the dose and then adding on another medication, according to the company.

The Diovan HCT and Exforge first-line approvals were based on several clinical trials in approximately 2,000 and 3,500 patients, respectively, in which both products demonstrated efficacy and tolerability in patients with mild to severe high blood pressure, according to Novartis.

Diovan HCT was approved in the U.S. in 1998 for second-line treatment of high blood pressure, and Exforge was approved in 2007.