Allergan’s Hypertension Combination Drug Nabs FDA Approval

Allergan has clinched FDA approval for its hypertension treatment Byvalson, the first fixed-dose combination of a beta blocker and angiotensin II receptor blocker in the U.S.

The approval is based on a Phase 3 trial that evaluated Byvalson’s efficacy in roughly 4,100 patients with Stage 1 or 2 hypertension. The randomized study demonstrated that the nebivolol and valsartan combination significantly lowered diastolic and systolic blood pressure from baseline compared to either agent alone.

The drug contains a fetal toxicity warning for pregnant women to discontinue use because the renin-angiotensin system in the product can reduce fetal renal function and increase fetal and neonatal morbidity and death.