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8 Jun 2016

USFDA nod for Allergan’s FDC Byvalson (nebivolol and valsartan) 5 mg/ 80 mg tablets for hypertension

Allergan plc got approval of Byvalson (nebivolol and valsartan) 5 mg/ 80 mg tablets, by the US Food and Drug Administration (FDA) for the treatment of hypertension to lower blood pressure.
Byvalson is the first and only fixed-dose combination (FDC) of a beta blocker (BB) and angiotensin II receptor blocker (ARB) available in the US.
The FDA approval of Byvalson was based on a phase 3, double-blind, placebo-controlled, dose-escalating, 8-week efficacy and safety study, published in The Lancet, which randomized approximately 4,100 patients with Stage 1 or 2 hypertension. In this pivotal efficacy and safety study, treatment with the FDC of nebivolol and valsartan for 4 weeks demonstrated statistically significant reductions from baseline in diastolic and systolic blood pressure versus either nebivolol alone or valsartan alone.
Nebivolol (marketed in the US as Bystolic) is a beta-adrenergic receptor blocking agent that is preferentially beta-1 selective up to and including the 10 mg dose and in extensive metabolizers. While nebivolol’s mechanism of action has not been definitively established, possible factors include vasodilation and decreased peripheral vascular resistance (PVR), reduced heart rate and myocardial contractility, suppression of renin, and reduced sympathetic activity.
Valsartan is an angiotensin II receptor blocker (ARB) that blocks the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby blocking its vasoconstrictor and aldosterone-secreting effects.
As of 2015 data, the worldwide exposure of each component drug has been ~50 million patient-years for nebivolol and ~200 million patient-years for valsartan.

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