Regulatory Committee Advises Against Approval of Actavis' Hypertension Treatment

The FDA's Cardiovascular and Renal Drugs Advisory Committee has recommended against the approval of Actavis' fixed-dose combination of nebivolol and valsartan for the treatment of hypertension.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has recommended against the approval of Actavis' fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. However, the new drug application (NDA) still awaits a final decision from the FDA, which Actavis expects by the fourth quarter of 2014.

"Although we are disappointed in the committee's recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension," said David Nicholson, Senior Vice President of Global Brands Research and Development for Actavis, in a press release. "We remain confident in the safety and efficacy of the combination of these 2 widely used and well-tolerated treatments, and we look forward to working with the FDA as it completes its review."

The FDA committee voted 6 to 4 against recommending the drug’s approval.

In an efficacy study published in The Lancet, the fixed-dose combination of nebivolol and valsartan met its primary and key secondary endpoints of demonstrating reductions in diastolic and systolic blood pressure from baseline at 8 weeks in patients with hypertension, compared to nebivolol or valsartan alone.

Two-thirds of hypertension patients require one or more drugs to achieve their blood pressure goals, Actavis noted. Nebivolol has been shown to lower blood pressure, while valsartan has proven to be an effective antihypertensive agent.

According to the National Institute for Health Statistics, 30% of adults in the United States have hypertension, which is often referred to as a “silent killer.”