Actavis plc report that the US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted to recommend against approval of Actavis’ new drug application (NDA) for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. The committee vote was six to four recommending against approval.

​The committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for the fixed-dose combination of nebivolol and valsartan by the fourth quarter of 2014.

​Nebivolol/valsartan (5/80 mg, 5/160 mg, 10/160 mg, 10/320 mg, and 20/320 mg) is an investigational fixed-dose combination. It combines two FDA approved, once-daily, blood pressure-lowering agents with different mechanisms of action. It is being evaluated as a potential treatment for hypertension in patients who need combination therapy.

Nebivolol (marketed in the US as Bystolic by Actavis through its subsidiary Forest Laboratories) is indicated for the treatment of hypertension and is effective at lowering blood pressure when taken alone or in combination with other antihypertensive agents, such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and/or diuretics. Valsartan is a well-established ARB, It is the active ingredient in Novartis’ Diovan, and it is also off-patent and provided by generic-drug manufacturers.   

Source: Actavis