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Xofluza (Baloxavir) & Signal Identification

    Basic Details
    Last Updated
    Tuesday, June 25, 2024
    Original Posting Date
    Health Outcome(s)
    signal identification
    Signal Identification
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    FDA initiated this study in Sentinel to explore the use of TreeScanTM to support safety signal identification for baloxavir. Baloxavir is a first-in-class influenza-specific endonuclease inhibitor approved for acute uncomplicated influenza or post-exposure prophylaxis in adult and pediatric patients. TreeScan is a signal identification approach that scans thousands of health outcomes simultaneously while adjusting for multiple scenarios that can be used to monitor the underlying assumption of no clinical differences.

    The goal of the study was to understand if there is an increased risk of safety outcomes in patients who received baloxavir versus in patients who received the comparator drug oseltamivir, a first-line influenza treatment and prophylactic having a different mechanism of action and greater postmarketing exposure than baloxavir. This study did not identify new safety issues with baloxavir as treatment or prophylaxis for influenza compared to oseltamavir in a large sample of real-world adult and pediatric patients, adding to the larger body of safety evidence for baloxavir.