FDA did not approve nebivolol/valsartan combination to treat hypertension

Actavis plc announced that it received a complete response letter from the FDA indicating that its fixed-dose combination of nebivolol and valsartan for treatment of hypertension would not be approved at this time.

The agency’s decision follows a vote by its Cardiovascular and Renal Drugs Advisory Committee in September, in which members voted 4-6 against recommending approval for the fixed-dose combination.

The panel members had expressed concern that the effect size of the combination was not much greater than that of nebivolol alone. In contrast, they said, other fixed-dose combinations approved for hypertension treatment have a much greater effect size compared with their individual components.

“Although we are disappointed in the receipt of a complete response letter, Actavis remains committed to bringing treatments to market that addresses the significant public health issue of [CVD],” David Nicholson, senior vice president of Actavis Global Brands R&D, said in a press release. “Bystolic [nebivolol] is a safe and effective option that is commonly used in combination with other antihypertensive medications to help patients reach [BP] treatment goals. We will review the complete response and determine the appropriate next steps.”

Actavis acquired the sponsor of the application, Forest Laboratories, in July. Nebivolol is a vasodilating beta-blocker. Valsartan is an angiotensin receptor blocker.