Baloxavir Marboxil: A Review in Acute Uncomplicated Influenza
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ADIS DRUG EVALUATION
Baloxavir Marboxil: A Review in Acute Uncomplicated Influenza Matt Shirley1
© Springer Nature Switzerland AG 2020
Abstract Baloxavir marboxil (Xofluza®; hereafter referred to as baloxavir), the prodrug of baloxavir acid, is a first-in-class, small molecule inhibitor of the polymerase acidic (PA) protein subunit of the influenza virus polymerase complex. Baloxavir (after conversion to baloxavir acid) acts to block influenza virus replication by inhibiting the cap-dependent endonuclease activity of the PA protein. Taken orally as a single dose, baloxavir is approved in the USA for the treatment of acute uncomplicated influenza in patients ≥ 12 years of age who have been symptomatic for ≤ 48 h. Data from randomized, double-blind, placeboand oseltamivir-controlled phase III trials have shown that baloxavir is efficacious in improving influenza symptoms both in otherwise healthy adolescents and adults and in those at high risk of influenza complications, displaying similar efficacy to that of oseltamivir. Furthermore, there is evidence that baloxavir can reduce influenza viral load more rapidly than oseltamivir. Baloxavir has activity against influenza A and B viruses (including strains resistant to neuraminidase inhibitors) and is well tolerated. Evidence of the emergence and likely human-to-human transmission of variant viruses with reduced susceptibility to baloxavir highlights the importance of monitoring and surveillance for changes in influenza virus drug susceptibility patterns. However, currently available evidence suggests that baloxavir, with the benefits of a single oral dose regimen, provides a useful alternative to neuraminidase inhibitors for the treatment of acute uncomplicated influenza in adolescents and adults.
1 Introduction Despite wide availability and use of vaccines against the disease, influenza represents a serious ongoing health issue [1, 2]. Globally, seasonal influenza is estimated to be responsible for 290,000–650,000 respiratory deaths each year [3]. In the USA, influenza infections were estimated to be responsible for 490,600 hospitalizations and 34,200 deaths during the 2018–2019 influenza season [4].
Additional information for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.11929797. The manuscript was reviewed by: S. Gravenstein, Department of Health Services, Policy & Practice School of Public Health and the Alpert Medical School Department of Medicine, Brown University, and Providence Veterans Administration Medical Center, Providence, RI, USA; L. Naesens, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium. * Matt Shirley [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
Baloxavir marboxil: clinical considerations in acute uncomplicated influenza First-in-class influenza virus endonuclease inhibitor Convenient and practical single oral dose regimen, with bodyweight-based dosing Reduces the time to im
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