Advisers to the US Food and Drug Administration have narrowly voted against recommending the firm’s combination of nebivolol and valsartan for the treatment of hypertension.

The agency’s Cardiovascular and Renal Drugs Advisory Committee voted six to four against approval of Actavis' New Drug Application for the fixed-dose combination of the latter’s Bystolic (nebivolol) and valsartan, the active ingredient in Novartis’ off-patent Diovan. The panel were not convinced that the combo worked better than each of the drugs on their own.

David Nicholson, head of global brands R&D at Actavis, said the firm is disappointed with the committee’s decision, but “we remain fully committed to supporting the NDA for this important potential new treatment option”. He added that “we remain confident in the safety and efficacy of the combination of these two widely-used and well-tolerated treatments, and we look forward to working with the FDA as it completes its review”.

Actavis got hold of the combo and Bystolic through its $28 billion acquisition of Forest Laboratories this summer.