FDA Approves Allergan's Combination Therapy for Hypertension

By Reuters Staff

June 07, 2016

(Reuters) - The U.S. Food and Drug Administration approved Allergan Plc's treatment for hypertension, the company said on Monday.

The drug, Byvalson, is a fixed-dose combination of two FDA-approved blood pressure lowering agents -- the beta-blocker Nebivolol and the angiotensin II receptor blocker Valsartan.

Byvalson is the first and only fixed-dose combination of a beta blocker and angiotensin II receptor blocker, the company said.

The two drugs fight hypertension using different mechanisms of action and are administered once a day.

Byvalson was tested against a placebo in two late-stage trials and also showed patients given the drug had a statistically significant reduction in blood pressure than those given either just Nebivolol or Valsartan, Allergan said.

The treatment is expected to hit the market by the second half of 2016, the company added in its statement.