Acombination therapy called Byvalson has been approved by the FDA to treat high blood pressure.
Taken together once a day in a fixed dose pill from Allergan (Parsippany, NJ; Dublin, Ireland), the two drugs—Nebivolol and Valsartan—work by using different mechanisms to lower blood pressure.
Nebivolol (marketed in the US as Bystolic) is a beta-adrenergic receptor blocking agent. While the drug’s mechanism of action “has not been definitively established,” the company suggested that its actions might include vasodilation and decreased peripheral vascular resistance (PVR), reduced heart rate, and myocardial contractility and renin suppression.
Valsartan (brand name Diovan) is an angiotensin II receptor blocker that blocks the binding of angiotensin II to the AT1 receptor in many tissues.
Allergan noted that Byvalson is the first and only fixed-dose combination of a beta blocker and angiotensin II receptor blocker available in the US.
FDA approval was based on a phase 3, double-blind, placebo-controlled, dose-escalating, 8-week efficacy and safety study, published in The Lancet.
The study randomized approximately 4100 patients with stage 1 or 2 hypertension to the drug. In an efficacy and safety study, treatment with the combination of Nebivolol and Valsartan for 4 weeks was associated with statistically significant reductions from baseline in diastolic and systolic blood pressure versus either Nebivolol or Valsartan alone. The overall rate of adverse events was similar across treatment groups and placebo.
Allergan said it expects Byvalson to be available in the second half of 2016.
