FDA narrowly rejects Actavis' blood pressure combo
- In a 6-4 vote, the FDA's Cardiovascular and Renal Drugs Advisory Committee has decided not to recommend Actavis' application for a fixed-dose combination of Bystolic (nebivolol) and valsartan.
- Valsartan is the active ingredient in Novartis' Diovan, whose patent has expired.
- The committee did not believe Actavis had presented sufficient data showing the company's combo therapy was more effective than monotherapy with either of the two drugs.
Actavis execs maintained a hopeful posture in light of the FDA's decision. "[W]e remain fully committed to supporting the NDA for this important potential new treatment option," said Actavis global brands R&D chief David Nicholson. "[W]e 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."
The news is certainly a letdown for Actavis -- but don't expect the company to shed too many tears over the rejection. Actavis snapped up Forest Laboratories -- and Bystolic -- over the summer in a $28-billion deal, and sales of the blood pressure drug have been consistently strong. Actavis' stock has also been hitting new highs this summer after several acquisitions.
- Pharma Times FDA advisers 'no' for Actavis blood pressure combo