A group of FDA advisers voted against recommending approval for a new combination blood-pressure treatment from Actavis ($ACT), clouding the future of a prospect the company picked up in its $28 billion buyout of Forest Laboratories.
The drug combines nebivolol, a hypertension medication marketed by Actavis as Bystolic, with valsartan, a generic copy of Novartis' ($NVS) blockbuster cardio treatment Diovan. Across Actavis' 5,000-patient clinical program, the fixed-dose combo met its primary and secondary endpoints of reducing blood pressure better than each component on its own, but the FDA's Cardiovascular and Renal Drugs Advisory Committee was unconvinced it provided a significant improvement over what's already out there, voting 6-4 against approval.
The FDA is not obligated to follow the whims of its advisers, though it often does. Actavis expects to hear final word from the agency on the product by year's end.
Forest, which filed for approval in February, had touted its cocktail as a potential game-changer, conveniently combining its own efficacious beta blocker with Novartis' top-selling ARB for patients who need dual therapy to get their hypertension under control. The company had high commercial hopes, as well, as an approved combo could boost sales for nebivolol, which grew nearly 18% to $535 million last year. Novartis' drug brought in about $3.5 billion in 2013, its last fully year before facing generic competition.
Whether the combination will ever see the U.S. market remains unclear, but Actavis is keeping up the faith in its inherited cardio contender.
"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," Senior Vice President David Nicholson said in a statement. "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."
- read the statement