Abstract
Baloxavir marboxil is a new drug developed in Japan by Shionogi to treat seasonal flu infection. This cap-dependent endonuclease inhibitor is a prodrug that releases the biologically active baloxavir acid. This new medicine has been marketed in Japan, the USA and Europe. It is well tolerated (more than 1% of the patients experienced diarrhea, bronchitis, nausea, nasopharyngitis, and headache), and both influenza A and B viruses are sensitive, although the B strain is more resistant due to variations in the amino acid residues in the binding site. The drug is now in post-marketing pharmacovigilance phase, and its interest will be especially re-evaluated in the future during the annual flu outbreaks. It has been also introduced in a recent clinical trial against COVID-19 with favipiravir.
Highlights
Baloxavir (1, BX, Figure 1), called baloxavir acid or BXA, is the active metabolite of the prodrug baloxavir marboxil (BXM, 2) which is marketed as Xofluza®
Main outcomes: proportion of subjects who are infected with influenza virus (RT-PCR positive), and present with fever and at least one respiratory symptom
Baloxavir marboxil is clearly an antiviral agent that needs to confirm its interest as treatment against flu, despite the good results obtained during the clinical trial evaluations and its clinical use in Japan; the University of Washington (USA); and, more recently, Europe
Summary
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Two facts must be kept in mind: on the one hand, the flu epidemic during the First World War was supposed to have killed more soldiers that the war itself, and, on the other hand, there is the growing fear of a flu pandemic of which the H1N1 outbreak of 2009 was a harbinger, with a high death toll With this in view, the development of baloxavir is an example of putative new anti-flu drugs that are looming in the future. Baloxavir (1, BX, Figure 1), called baloxavir acid or BXA, is the active metabolite of the prodrug baloxavir marboxil (BXM, 2) which is marketed as Xofluza® It is the first approved anti-flu drug since the marketing of the neuraminidase inhibitors (NI) oseltamivir (OMV) and zanamivir in 1999 (USA), laninamivir in 2010 (Japan), and peramivir in 2014.
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