The FDA’s Cardiovascular and Renal Drug Advisory Committee will meet Sept. 9 and 10 to review a proposed treatment for hypertension and discuss other fixed-dose combinations.

On Sept. 9, the panel will review a New Drug Application for nebivolol/valsartan fixed-dose combination tablets. Nebivolol (Bystolic), an antihypertensive agent, and valsartan, an ARB, both have been approved by the FDA. Forest Laboratories, now part of Actavis, filed for the approval.

Forest had conducted a combination fixed dose trial to assess safety and effectiveness, which under the combination rule compares the combination against the highest approved dose of each component drug. In 2013, Forest announced that it met its primary endpoint with results showing a significant reduction in diastolic blood pressure compared with nebivolol alone and valsartan alone at eight weeks.

The trial also met its secondary endpoint, with a change from baseline in systolic blood pressure at eight weeks. The most common adverse events were fatigue and dizziness.

Doses under review include 5/80 mg, 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg.

On Sept. 10, the panel will discuss the clinical utility of a fixed combination of an antihypertensive agent, aspirin and a statin for patients with a history of cardiovascular disease. The combination is proposed as a treatment to reduce the risk of cardiovascular death, nonfatal MI and nonfatal stroke.