Actavis Confirms Receipt Of CRL For Nebivolol/Valsartan FDC For Hypertension

(RTTNews) - Actavis plc (ACT) confirmed Wednesday that it has received a complete response letter from the U.S. Food and Drug Administration for its New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension.

"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. "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."

Actavis said data submitted to the FDA in support of approval of the NDA included a single phase III randomized, controlled trial of about 4,100 patients. In the pivotal efficacy study, the fixed-dose combination of nebivolol and valsartan met its primary and key secondary endpoints, demonstrating statistically significant reductions from baseline in diastolic and systolic blood pressure at eight weeks in patients with hypertension, compared to both nebivolol alone and valsartan alone, including either monotherapy agent at its highest doses. The rate of patients experiencing at least one treatment-emergent adverse event was similar across treatment groups and placebo.

In addition, a 52-week open-label safety study was conducted to describe the long-term safety profile of the nebivolol/valsartan combination.