Please login to the form below

Not currently logged in

FDA panel votes against Actavis hypertension combo

Places a question mark over the combination of Bystolic and Diovan

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.

Article by
Thomas Meek

10th September 2014

From: Sales, Regulatory



Featured jobs

Subscribe to our email news alerts


Add my company

We’re IGNIFI. An independent creative agency, we help spark and sustain successful brands for some of the biggest names in...

Latest intelligence

Marketing to healthcare professionals – what’s the key ingredient missing from most campaigns?
What do you think is the difference between a campaign developed to win a share-of-mind with consumers and a campaign designed to gain the attention of healthcare professionals?...
What everyone forgets about good organisational change in pharma
Natasha Cowan speaks to Daphne Chung, Head of Organisational Transformation, to learn how she ensures smooth organisational change that takes all stakeholders into account....
Live from Singapore: Oncology in APAC - Evaluating the opportunity for novel therapies
Live webinar: Tuesday 11th December 2018,16:00 SGT / 17:00 JST...