Allergan Reports FDA Approval Of BYVALSON

(RTTNews) - Allergan plc (AGN) announced the approval of BYVALSON (nebivolol and valsartan) 5 mg/ 80 mg tablets, by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension to lower blood pressure. BYVALSON is the first and only fixed-dose combination (FDC) of a beta blocker or BB and angiotensin II receptor blocker (ARB) available in the U.S.

Hypertension represents a significant public health problem with high prevalence in the U.S. Hypertension often has no warning signs or symptoms and has been associated with serious cardiovascular (CV) risks, such as stroke, heart failure, and myocardial infarction. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the beta-blocker class to which nebivolol principally belongs and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with BYVALSON.

Allergan expects BYVALSON to be available in the second-half of 2016.