FDA approves Allergan hypertension fixed-dose combo, Byvalson

pharmafile | June 7, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Allergan, FDA, US, angiotensin ii, approval, beta blocker, byvalson, hypertension, nebivolol, valsartan 

Allergan has announced that the US Food and Drug Administration (FDA) has approved its fixed-dose combination, Byvalson (nebivolol and valsartan), for the treatment of hypertension to lower blood pressure.

Byvalson becomes the first and only fixed-dose combination of a beta blocker and angiotensin II receptor blocker available in the US to treat hypertension. The condition represents a significant public health burden as it has been associated with serious cardiovascular risks, such as stroke, heart failure and heart attack. By lowering blood pressure with Byvalson, this greatly reduces the risks of these adverse events.

A recent Phase III trial, published in The Lancet, showed that the drug combo demonstrated statistically significant reductions from baseline in diastolic and systolic blood pressure versus either nebivolol alone or valsartan alone.

David Nicholson, chief R&D officer at Allergan, comments: “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 US 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.”

William B White, chief of the division of hypertension at the Calhoun Cardiology Center, says: “Nebivolol and valsartan are used widely in the management of hypertension and are effective drugs. The new fixed-dose combination Byvlason, that includes these two therapies, offers reduction of blood pressure through multiple mechanisms of action.”

Allergan indicates that Byvalson will be made available in the second half of 2016.

Sean Murray

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