The FDA recently approved the use of baloxavir marboxil (baloxavir) in patients aged
12–64 years with uncomplicated influenza [
[1]
]. The effectiveness of baloxavir had been tested in one phase III trial named CAPSTONE-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
[2]
]. 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.Keywords
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References
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
- Baloxavir Marboxil for uncomplicated influenza in adults and adolescents.N. Engl. J. Med. 2018; 379: 913-923
- Enrichment of Clinical Study Populations.Clin Pharmacol Ther. 2010; 88: 774-778
- Review Report Xofluza 10 mg and 20 mg [Internet].(Available via:)www.pmda.go.jp/files/000225380.pdfDate: 8 February 2018
- XOFLUZA™ (baloxavir marboxil) [label].(Available via:)www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdfDate: October 2018
World Health Organization. Global status report on noncommunicable diseases 2014. Available via: apps.who.int/medicinedocs/documents/s21756en/s21756en.pdf
Article info
Publication history
Published online: March 08, 2019
Accepted:
December 15,
2018
Received:
December 11,
2018
Identification
Copyright
© 2018 Published by Elsevier B.V. on behalf of European Federation of Internal Medicine.
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Access this article on ScienceDirectLinked Article
- Baloxavir for influenza: Enrichment obscured lack of effect in North-American adults. Author's reply.European Journal of Internal MedicineVol. 72
- PreviewIn response to our comment[1], Dr Portsmouth and colleagues provide additional information about the results of the CAPSTONE-1 trial [2], which we appreciate. In our comment, we underlined that the composition of the study population should have been taken into account when the study results were analysed, interpreted and presented.
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- Comment to: Baloxavir efficacy in North American AdultsEuropean Journal of Internal MedicineVol. 72
