FDA
10th September 2014

FDA Panel Does Not Support Approval for Nebivolol/Valsartan Combination Drug

On September 9th, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) discussed new drug application (NDA) 206302.

FDA Panel Does Not Support Approval for Nebivolol/Valsartan Combination Drug

On September 9th, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) discussed new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forest Laboratories, Inc. (recently acquired by Ireland-based generic drug company, Actavis), for the proposed indication of the treatment of hypertension.

During this meeting, there were six discussion questions and one voting question. CRDAC voted six to four against approval of the nebivolol/valsartan fixed-dose combination drug for hypertension.

Data presented at the meeting included efficacy and safety results from a Phase III study involving almost 5,000 subjects. In the pivotal efficacy study published in The Lancet, the fixed-dose combination drug met both its primary and key secondary endpoints, demonstrating statistically significant reductions from baseline in both diastolic and systolic blood pressure at eight weeks in patients with hypertension versus nebivolol alone and valsartan alone. The adverse event profile for this study was similar to that observed with the use of nebivolol and valsartan alone and placebo. Furthermore, a 52-week open-label safety study supported the favorable long-term safety profile of the nebivolol/valsartan combination drug.

James DeLemos, a panelist and cardiology service chief at Parkland Memorial Hospital in Dallas, Texas stated that, “Approving a drug with a very small effect like this will lead to choosing this agent over other combinations or other individual agents that work better.” He also noted that he didn’t feel a need for “47 combinations of blood pressure medicines.”

Importantly, nebivolol (marketed in the USA as Bystolic by Actavis subsidiary Forest Labs) 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 ACEIs, ARBs, and/or diuretics. Valsartan is the active ingredient of Novartis’ drug Diovan (now off-patent), has been well studied in many different patient populations and is an effective antihypertensive agent.

The FDA is not bound by their committee’s recommendation; however, the Agency takes it into consideration when reviewing the application. Actavis expects FDA action on its NDA for the fixed-dose combination of nebivolol and valsartan by the fourth quarter of 2014.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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