Allergan Gets FDA Approval For BYVALSON

Allergan plc AGN revealed the FDA has given its approval for its BYVALSON (nebivolol and valsartan) 5 mg/ 80 mg tablets, for the treatment of hypertension to lower blood pressure. The company said that BYVALSON was the first and only fixed-dose combination (FDC) of a beta blocker (BB) and angiotensin II receptor blocker (ARB) available in the United States.

Allergan Chief R&D Officer, David Nicholson, reacted, "Achieving blood pressure control is critical to reducing the risk of serious and life-threatening cardiovascular events. There remains a need for new therapies, as observed by the nearly half of patients in the U.S. who remain uncontrolled. We are pleased with the FDA approval of BYVALSON, which will provide physicians a new fixed dose combination therapy treatment option for patients affected by hypertension."

The company said the FDA approval of BYVALSON was based on a final state, double-blind, placebo-controlled, dose-escalating, 8-week efficacy and safety study, published in The Lancet, which randomized about 4,100 patients with Stage 1 or 2 hypertension. According to the company, 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 four-week period.

Allergan said hypertension represented a significant public health problem with high prevalence in the U.S. Hypertension often has no warning signs or symptoms and was associated with serious cardiovascular (CV) risks, like stroke, heart failure, and myocardial infarction. The company added that lowering blood pressure reduced the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

The company said these gains were 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.