Actavis plc (ACT) announced that the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted against the approval (in the ratio of 6:4) of Actavis' fixed-dose combination (FDC) of Bystolic (nebivolol) and Novartis’ (NVS) Diovan (valsartan) for the potential treatment of hypertension.
Although it is not mandatory, the FDA generally takes the recommendations of the advisory committee into account before approving a candidate. A final decision from the FDA on Actavis’ New Drug Application (NDA) of the combination treatment is expected by the fourth quarter of 2014.
The NDA was based on efficacy and safety data from a phase III study. It was observed from the study that the FDC of Bystolic and Diovan met its primary and key secondary endpoints. The FDC demonstrated statistically significant reductions from baseline in diastolic and systolic blood pressure at eight weeks in patients suffering from hypertension as compared to Diovan and Bystolic alone.
The safety profile of the FDC was supported by an open label 52-week study.
The unfavorable recommendation from the CRDAC was quite disappointing as a potential approval of the FDC will further expand the patient population for Bystolic. We remind investors that Actavis had acquired Bystolic through its acquisition of the erstwhile Forest Labs in Jul 2014.
Actavis is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Mallinckrodt plc (MNK) and Akorn, Inc. (AKRX). Both hold a Zacks Rank #1 (Strong Buy).
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