Actavis faces a question mark over its new hypertension combo after an advisory committee to the US FDA narrowly voted against the drug’s recommendation.
The expert panel voted six to four against the US approval of the drug, which combines Actavis’ Bystolic (nebivolol) with fellow blood pressure treatment valsartan.
Regulators raised questions over whether the combination drug was a more effective treatment for people with high blood pressure than either of the individual medicines when used as a monotherapy at the highest approved dose.
According to a report published by the FDA’s Division of Cardio-Renal Drug Products, there was no apparent difference in ambulatory blood pressure monitoring while the size of effect on diastolic blood pressure was also in doubt.
Despite this negative outcome, Actavis said it was confident of the drug’s potential as a hypertension treatment ahead of the FDA’s final decision, which is planned for the fourth quarter of 2014.
David Nicholson, senior VP, global brands research and development at Actavis, said: “Although we are disappointed in the committee’s recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension.”
Actavis gained the rights to nebivolol when it acquired Forest Laboratories earlier this year. The drug was approved in the US under the brand name Bystolic in 2007 and recorded sales of $142.9m for Forest from April 2013 to March 2014.
Valsartan – an angiotensin II receptor blocker – was until recently marketed solely by Novartis as Diovan, becoming one of the world’s biggest selling drugs with sales topping $4bn. However, the drug’s patent expiration in 2012 opened the door to generic versions and eventually allowed for Actavis to use valsartan in a combination therapy.
Meanwhile, Novartis continues to investigate valsartan’s potential for use in combination with other therapies, including an enzyme blocker called neprilysin. The investigational treatment is known as LCZ696 and is being tested in chronic heart failure.