FDA approves Byvalson (nebivolol + valsartan) as a treatment for hypertension. -Allergan

Allergan plc announced the approval of Byvalson (nebivolol and valsartan) 5 mg/ 80 mg tablets, by the 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 U.S.

The FDA approval of Byvalson was based on a Phase III, 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. The overall rate of adverse events was similar across treatment groups and placebo during this 4 week period.

See- "Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study"- Prof Thomas D Giles, MDcorrespondenceemail, Prof Michael A Weber, MD, Prof Jan Basile, MD, Prof Alan H Gradman, MD, David B Bharucha, MD, Wei Chen, PhD, Manoj Pattathil, MSc, for the NAC-MD-01 Study Investigators DOI: http://dx.doi.org/10.1016/S0140-6736(14)60614-0. The Lancet.-Volume 383, No. 9932, p1889�1898, 31 May 2014.