A U.S. Food and Drug Administration (FDA) advisory panel has voted to recommend against the approval of Actavis’ hypertension combination drug, which containsboth Bystolic (nebivolol) and the blood pressure treatment valsartan.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee convened on Sept. 9 to review data from a phase III efficacy and safety study of the nebivolol/valsartan fixed-dose oral drug, published in The Lancet. Although both components of the drug were previously approved for use in the US for treatment of hypertension, the committee questioned the effectiveness of the combination drug when compared to that of monotherapies.

In a statement released Sept. 9, a member of the committee remarked, “it is... appropriate to consider whether the combination of nebivolol plus valsartan is better tolerated than are both monotherapies, or whether the net effects in terms of blood pressure and tolerability commend the combination.”

Despite the committee’s recommendation against approval, the FDA will make the final decision by the fourth quarter of 2014. Actavis has stated that it believes the fixed-dose combination is an “important potential new treatment option for patients with hypertension”. The company also remarked that it is committed to supporting the FDA’s final review.

Keywords: Advisory Committees, Benzopyrans, Blood Pressure, Ethanolamines, Hypertension, Tetrazoles, United States Food and Drug Administration, Valine

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