In addition, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and above. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus.
This approval follows the positive opinion received from the Committee for Medicinal Products for Human Use (CHMP) on November, 2020, and is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.1, 2, 3 Xofluza is available in more than 30 countries for the treatment of influenza types A and B.
About CAPSTONE-1 Study1
The CAPSTONE-1 study was a Phase III, randomized, double-blind, multicenter, parallel-group, placebo- and active-controlled study that enrolled 1,436 otherwise healthy patients diagnosed with influenza. In this study, Xofluza (baloxavir marboxil) significantly reduced the duration of influenza symptoms by more than a day compared with placebo (median time; 53.7 hours versus 80.2 hours; p
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