Allergan Announces FDA Approval of BYVALSON™ (nebivolol and valsartan)

nebivolol                               valsartan

DUBLIN, June 6, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today 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 (BB) and angiotensin II receptor blocker (ARB) available in the U.S.

"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," said David Nicholson, Chief R&D Officer at Allergan. "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."

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.

"The majority of patients with hypertension require two or more medications to achieve their blood pressure goals," said William B White, MD Professor of Medicine and Chief of the Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center at UConn Health in Farmington and immediate past president of the American Society of Hypertension. "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 reduction of blood pressure through multiple mechanisms of action."

The FDA approval of BYVALSON was based on a Phase 3, 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.

Allergan expects BYVALSON to be available in the 2nd half of 2016.

About BYVALSON

BYVALSON (nebivolol/valsartan) 5 mg/ 80 mg tablet is a fixed-dose combination that combines two FDA approved, once daily, blood pressure lowering agents with different mechanisms of action.

Nebivolol (marketed in the U.S. as BYSTOLIC) is a beta-adrenergic receptor blocking agent that is preferentially beta-1 selective up to and including the 10 mg dose and in extensive metabolizers. While nebivolol's mechanism of action has not been definitively established, possible factors include vasodilation and decreased peripheral vascular resistance (PVR), reduced heart rate and myocardial contractility, suppression of renin, and reduced sympathetic activity.

Valsartan is an angiotensin II receptor blocker (ARB) that blocks the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby blocking its vasoconstrictor and aldosterone-secreting effects.

As of 2015 data, the worldwide exposure of each component drug has been ~50 million patient-years for nebivolol and ~200 million patient-years for valsartan.

INDICATIONS AND USAGE

BYVALSON is indicated for the treatment of hypertension, to lower blood pressure.­­ BYVALSON may be used alone or in combination with other antihypertensive agents. 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.

About Allergan

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com.

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