The phase 3, double blind study evaluated the safety, pharmacokinetics and efficacy of Xofluza vs oseltamivir in otherwise healthy children with a confirmed influenza infection (N=176). Patients were assigned to 1 of 2 cohorts (aged 5 to less than 12 years; aged 1 to less than 5 years) and randomized to receive 1 dose of baloxavir marboxil or oseltamivir twice daily for 5 days. The primary endpoint of the study was the proportion of patients with adverse events or severe adverse events up to study day 29.
Results showed that baloxavir marboxil was comparable to oseltamivir for reducing the duration of influenza symptoms, including fever. In addition, treatment with baloxavir marboxil, which was administered as an oral suspension, was found to be well-tolerated.
Additional findings from this study are expected to be presented at an upcoming medical meeting. The treatment is also being investigated in a phase 3 study (MINISTONE-1) in children under the age of 1.
“As a one-dose oral suspension medicine, Xofluza could potentially provide a convenient treatment option for children with the flu, and we look forward to sharing these data with health authorities around the world,” said Sandra Horning, MD, chief medical officer and head of Global Product Development.
Originally approved in October 2018, Xofluza, a first-in-class polymerase acidic endonuclease inhibitor, is indicated for the treatment of acute uncomplicated influenza in patients ≥12 years old who have been symptomatic for no more than 48 hours.
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