Genentech’s Xofluza demonstrates reduction in household flu spread in Phase III trial

USA—Genentech, a member of the Roche Group, has announced that the New England Journal of Medicine has published a comprehensive analysis of the Phase III CENTERSTONE trial for Xofluza® (baloxavir marboxil), an antiviral medication designed to treat influenza.

This global study marks a significant milestone, as it is the first phase III trial to demonstrate that an antiviral can reduce the transmission of a respiratory virus within households.

The CENTERSTONE trial enrolled over 4,000 participants across 272 sites worldwide, focusing on individuals aged five to 64 who had been diagnosed with influenza.

The primary goal of the study was to determine whether a single, oral dose of Xofluza taken by an infected person could lower the risk of household members contracting the virus.

The results were promising: Xofluza reduced the odds of untreated household members becoming infected by 32% compared to placebo.

For the key secondary endpoint-measuring the reduction of symptomatic influenza transmission-Xofluza showed a clinically meaningful benefit, though this did not reach statistical significance.

Importantly, the medication was well tolerated, with no new safety concerns identified during the trial.

Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, emphasized the broader implications of these findings.

 He noted that this is the first time an antiviral has been shown to reduce influenza transmission within a household, which could have far-reaching public health benefits.

Dr. Garraway also highlighted the ongoing need for effective solutions to ease the burden of influenza on society, especially as multiple respiratory viruses, including COVID-19, continue to circulate.

The findings from the CENTERSTONE trial have been submitted to regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for review.

This step could pave the way for expanded use of Xofluza in efforts to control influenza outbreaks both during seasonal epidemics and potential pandemics.

Influenza remains a major global health concern, infecting an estimated one billion people and causing up to 650,000 deaths worldwide each year.

 A significant portion of influenza transmission-about one-third-occurs within households.

Moreover, influenza leads to substantial economic costs, with many working adults missing approximately two days of work per illness, and a majority reporting that they continue to work despite having symptoms.

Xofluza is a first-in-class, single-dose oral antiviral that works by inhibiting the cap-dependent endonuclease protein, thereby blocking viral replication.

This innovative mechanism of action has shown efficacy against a broad range of influenza viruses, including strains resistant to other antivirals and certain avian flu viruses, in laboratory studies.

 Xofluza is already approved in over 80 countries for the treatment of uncomplicated influenza types A and B, and in the U.S., it is authorized for use in people five years and older for both treatment and post-exposure prevention.

The development and commercialization of Xofluza is a collaboration between Roche and Shionogi & Co., Ltd., with Roche holding global rights outside of Japan and Taiwan.

The CENTERSTONE trial and related research have been supported in part by the U.S. Department of Health and Human Services and the Biomedical Advanced Research and Development Authority.

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