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FDA reviewers question nebivolol/valsartan benefit

September 6, 2014 1:21 AM UTC

FDA reviewers questioned whether a fixed-dose combination of nebivolol and valsartan from Actavis plc (NYSE:ACT) provides a "clinically meaningful" benefit in patients with hypertension. The reviewers noted the combo led to a greater reduction in systolic and diastolic blood pressure vs. placebo and the individual components as monotherapies in a Phase III trial. However, the reviewers said "one might reasonably ask" whether the differences are "too small to be useful."

The reviewers did note that the highest dose of the nebivolol/valsartan combo may have a better tolerability and safety profile than the highest approved dose of nebivolol. Actavis markets the adrenergic receptor beta 1 ( ADRB1) antagonist in the U.S. as Bystolic. Valsartan is a generic small molecule angiotensin II receptor (type AT1) antagonist. ...