Byvalson Approved to Treat Hypertension

The FDA has approved Allergan’s nebivolol and valsartan (Byvalson) for the treatment of hypertension.

The 5 mg/80 mg tablets are the first and only fixed-dose combination of a beta blocker and angiotensin II receptor blocker.

"The majority of patients with hypertension require 2 or more medications to achieve their blood pressure goals," William B White, MD, professor of medicine and chief of the Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center at UConn Health, said in a press release. "Nebivolol and valsartan are used widely in the management of hypertension and are effective drugs. The new fixed-dose combination Byvalson, that includes these 2 therapies, offers a reduction of blood pressure through multiple mechanisms of action."

The FDA based its approval on the results of a phase 3, double-blind, 8-week study. More than 4000 patients with stage 1 or 2 hypertension were randomized to intervention or control groups.

The study showed that there were significant reductions in systolic and diastolic blood pressure in the patients who took Byvalson compared with those who took nebivolol or valsartan alone.

The study also demonstrated that adverse event rates were similar across the treatment and placebo groups.

Pregnant women should not take Bylvason, since it could cause injury or death to the fetus.

Allergan plans to make Bylvason available in the second half of 2016.