FDA approval for Allergan's Byvalson

The US Food and Drug Administration has approved marketing of a new fixed-dose combination of two FDA-approved blood pressure lowering agents.

The clearance is for Ireland-incorporated Allergan’s (NYSE: AGN) Byvalson (nebivolol and valsartan) 5mg/80mg tablets, 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 USA, according to Allergan, which expect to make the drug available in the USA in the second-half of this year.

"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," 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."