New England Journal of Medicine Publishes Phase III Data Showing Single-Dose Xofluza Significantly Reduces Influenza Virus Transmission
- CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus
- Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread of influenza virus, from an infected person to household members by 32%
- Reducing the spread of infection within households could help limit transmission within institutions and communities, potentially easing the burden of both seasonal and pandemic influenza on healthcare systems
Excerpt from the Press Release:
South San Francisco, CA — April 24, 2025 —
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the New England Journal of Medicine (NEJM) has published a detailed analysis of the Phase III CENTERSTONE trial of Xofluza® (baloxavir marboxil).The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced the odds of untreated household members contracting the virus by 32%. For the key secondary endpoint of influenza virus transmission resulting in symptoms, Xofluza showed a clinically meaningful reduction although statistical significance was not reached. Xofluza was well tolerated, with no new safety signals identified.
“This trial is the first to demonstrate an antiviral effect that reduces transmission of influenza viruses within a household. This result may potentially have broad-reaching implications for public health,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This publication reminds us of the ongoing societal need for solutions that can help ease the burden of influenza on society.”
Results from the CENTERSTONE trial have been submitted to health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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