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FDA Approves Hypertension Drug Byvalson (Nebivolol/Valsartan)

First fixed-dose beta blocker/ARB combo in the U.S.

Byvalson (nebivolol/valsartan, Allergan) 5 mg/80 mg tablets have won FDA approval for the treatment of patients with hypertension to lower blood pressure. Byvalson is the first fixed-dose combination (FDC) of a beta blocker (BB) and an angiotensin II receptor blocker (ARB) available in the United States.

The FDA’s decision was based on positive data from a phase 3, double-blind, placebo-controlled, dose-escalating efficacy and safety study, published in The Lancet, which enrolled approximately 4,100 patients with stage-1 or -2 hypertension. In this pivotal trial, treatment with the FDC of nebivolol and valsartan for four weeks demonstrated statistically significant reductions from baseline in diastolic and systolic blood pressure compared with either nebivolol alone or valsartan alone. The overall rates of adverse events were similar across the treatment groups and placebo during the four-week treatment period.

Nebivolol (Bystolic, Allergan) is a BB that is preferentially beta-1 selective up to and including the 10-mg dose and in extensive metabolizers. While the mechanism of action of nebivolol has not been definitively established, possible factors include vasodilation, decreased peripheral vascular resistance, reduced heart rate, myocardial contractility, renin suppression, and reduced sympathetic activity.

Valsartan is an ARB that blocks the binding of angiotensin II to the angiotensin II, type 1 (AT1) receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby blocking its vasoconstrictor and aldosterone-secreting effects.

Byvalson may be used alone or in combination with other antihypertensive agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a variety of pharmacological classes, including the BB class to which nebivolol principally belongs and the ARB class to which valsartan principally belongs. No controlled trials have demonstrated risk reduction with Byvalson.

Allergan expects the product to be available in the second half of 2016.

Source: Allergan; June 6, 2016.

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