Allergan announced that the Food and Drug Administration (FDA) has approved Byvalson (nebivolol and valsartan) tablets for the treatment of hypertension to lower blood pressure. This marks the first fixed-dose combination of a beta-blocker and angiotensin II receptor blocker (ARB).

Byvalson combines nebivolol and valsartan, two antihypertensive agents with different mechanisms of action. Nebivolol, marketed as Bystolic, is preferentially beta-1 selective up to and including the 10mg dose and in extensive metabolizers. Possible mechanisms of action include vasodilation and decreased peripheral vascular resistance, reduced heart rate and myocardial contractility, suppression of renin, and reduced sympathetic activity. Valsartan, marketed as Diovan, works by blocking the binding of angiotensin II to the AT1 receptor in various tissues, including vascular smooth muscle and the adrenal gland. This ultimately leads to vasoconstrictor and aldosterone-secreting effects. 

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The approval of Byvalson was supported by data from a Phase 3, double-blind, placebo-controlled, dose-escalating, 8-week efficacy and safety study that included about 4,100 patients with Stage 1 or 2 hypertension. The study showed that treatment with nebivolol/valsartan for 4 weeks resulted in statistically significant reductions from baseline in diastolic and systolic blood pressure vs. either nebivolol alone or valsartan alone. The rate of adverse events was similar between the treatment groups and placebo during the study period. Full study results were published in The Lancet.

Byvalson will be available as 5mg/80mg strength tablets in 30- and 90-count bottles. It is anticipated to launch in the 2nd half of 2016. 

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