Pfizer Inc. (NYSE:PFE) today reported the top-line results of an international Phase III clinical trial which compared the combination of VFEND® (voriconazole) and ERAXISTM (anidulafungin) to VFEND monotherapy for primary therapy of invasive aspergillosis (IA), a life-threatening invasive fungal infection that can develop as a complication in patients with compromised immune systems. The primary analysis of this double-blinded prospective randomized clinical trial was to compare mortality rates at six weeks after initiation of study treatment in patients with a diagnosis of proven or probable IA.
In the primary analysis, treatment with the combination of VFEND and ERAXIS resulted in a lower all-cause mortality rate at six weeks compared to VFEND alone. However, this difference in mortality did not achieve the pre-specified threshold for statistical superiority. The safety and tolerability of the combination of VFEND and ERAXIS in this study was similar to that of VFEND monotherapy.
Pfizer plans to submit the detailed results of the study to a future scientific meeting and/or a medical journal.