Nebivolol/valsartan regulatory update

FDA's Cardiovascular and Renal Drugs advisory committee voted 6-4 against approval of an NDA from Actavis for a fixed-dose combination of nebivolol and valsartan to treat hypertension. The product has a Dec. 24 PDUFA date. In briefing documents released ahead of the meeting, FDA reviewers questioned whether the combo provides a "clinically meaningful" benefit in patients with hypertension.

Actavis gained the nebivolol/valsartan combo through its acquisition of Forest Laboratories Inc., which markets nebivolol as Bystolic. In 2012, Forest acquired all U.S. and Canadian IP for the adrenergic receptor beta 1 ( ADRB1) antagonist from the Janssen Pharmaceutica N.V. unit of Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) (see BioCentury, April 9, 2012). ...