FDA Committee Recommends Against Actavis’ Hypertension Combo Treatment

An FDA advisory panel is recommending against approval of Actavis’ NDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension.

In a 6-to-4 vote last week, the agency’s Cardiovascular and Renal Drugs Advisory Committee said the combination of Actavis’ Bystolic (nebivolol) and Novartis’ Diovan (valsartan) didn’t lower blood pressure sufficiently compared with each of the drugs on its own, advisory committee member James De Lemos, M.D., of the University of Texas Southwestern Medical Center and Parkland Memorial Hospital in Dallas, said.

Actavis said it is disappointed with the recommendation, but remains confident in the efficacy and safety of the combination of the two treatments, which are widely used and well tolerated.

The company’s NDA proposed nebivolol/valsartan in five strengths: 5/80 mg, 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg.

In an efficacy study, the combo product showed statistically significant reductions in diastolic and systolic blood pressure at eight weeks versus both nebivolol alone and valsartan alone, Actavis said. The combo’s adverse event profile was similar to the monotherapies and placebo, it added.

Roughly 30 percent of U.S. adults have hypertension, according to the National Institutes of Health. Two-thirds of patients will require more than one drug to achieve blood pressure goals, Actavis said.

The FDA advisory committee’s recommendation is not binding on the agency, which makes the final decision on approval. The FDA has set a Dec. 24 goal for making a decision, according to an FDA briefing document. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.