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Baloxavir for influenza: Enrichment obscured lack of effect in North-American adults

Published:March 08, 2019DOI:https://doi.org/10.1016/j.ejim.2018.12.002
      The FDA recently approved the use of baloxavir marboxil (baloxavir) in patients aged 12–64 years with uncomplicated influenza [

      U.S. Food & Drug Administration. FDA Application Review Files - Drug Approval Package: Xofluza Film-Coated Tablets (Baloxavir marboxil). 7 Dec 2018. Available via: www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210854Orig1s000TOC.cfm

      ]. The effectiveness of baloxavir had been tested in one phase III trial named CAPSTONE-1 [
      • Hayden F.G.
      • Sugaya N.
      • Hirotsu N.
      • et al.
      Baloxavir Marboxil for uncomplicated influenza in adults and adolescents.
      ]. It consisted of two subtrials: one subtrial compared baloxavir (40 mg once) with placebo and oseltamivir in adult patients, and the other baloxavir with placebo in adolescent patients (total n = 1436). The trial was performed in Japan, the United States, and Canada. In the reported primary efficacy analysis, baloxavir reduced the time to alleviation of flu symptoms with 26.5 hours compared to placebo. However, an enriched study population has obscured baloxavir’s lack of effect in North-American adult patients.

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      References

      1. U.S. Food & Drug Administration. FDA Application Review Files - Drug Approval Package: Xofluza Film-Coated Tablets (Baloxavir marboxil). 7 Dec 2018. Available via: www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210854Orig1s000TOC.cfm

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        • et al.
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        • Japanese Pharmaceuticals and Medical Devices Agency
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        (Available via:)
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        (Available via:)
      2. World Health Organization. Global status report on noncommunicable diseases 2014. Available via: apps.who.int/medicinedocs/documents/s21756en/s21756en.pdf

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