FDA Approves Byvalson to Treat Hypertension

Allergan announced that it received approval from the US Food and Drug Administration (FDA) for Byvalson (nebivolol and valsartan) 5 mg/ 80 mg tablets to lower blood pressure in patients with hypertension.

This medication is the first and only fixed-dose combo of an angiotensin II receptor blocker (ARB) and a beta blocker, according to Allergan.

The approval was based on the results of an 8-week, double-blind, placebo-controlled, Phase 3 trial with dose escalation involving more than 4000 patients with Stage 1 or 2 hypertension. Patients receiving Byvalson for 4 weeks experienced significant reductions in diastolic and systolic blood pressure when compared to patients taking valsartan or nebivolol alone, the company reported.

Adverse events occurred at similar rates among all treatment groups, the company noted.

Allergan noted that Byvalson is scheduled for release in the latter half of 2016.

--Stephanie Vaccaro

Reference:

Allergan. Allergan announces FDA approval of BYVALSON™ (nebivolol and valsartan) [press release]. www.prnewswire.com. 2016 Jun 6.