Actavis Receives FDA Complete Response Letter
Actavis has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its new drug application (NDA) for the fixed-dose combination (FDC) of nebivolol and valsartan for the treatment of hypertension.
â€‹Nebivolol/valsartan combines two FDA approved, once-daily, blood pressure-lowering agents with different mechanisms of action. 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.
“Although we are disappointed in the receipt of a complete response letter, Actavis remains committed to bringing treatments to market that address the significant public health issue of cardiovascular disease,” said David Nicholson, senior vice president, Actavis Global Brands R&D, in a company statement. “Bystolic is a safe and effective option that is commonly used in combination with other antihypertensive medications to help patients reach blood pressure treatment goals. We will review the complete response and determine the appropriate next steps.”
In September 2014, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted to recommend against approval of Actavis’ NDA for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension.