Data from a phase III study shows a single dose of Xofluza reduces transmission of influenza from an infected person to household members.
RT’s Three Key Takeaways:
- Xofluza Reduces Flu Transmission – The phase III CENTERSTONE study demonstrated that a single oral dose of Xofluza significantly reduced the spread of influenza within households.
- Well-Tolerated with No New Safety Concerns – Xofluza was found to be well-tolerated, with no new safety signals identified during the study.
- First Global Study of Its Kind – The CENTERSTONE study is the first global phase III trial to show an antiviral can reduce the transmission of a respiratory viral illness, according to Genentech.
Genentech, a member of the Roche Group, announced positive topline results of the phase III CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses.
The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. Xofluza was well tolerated with no new safety signals identified.
CENTERSTONE is the first global phase III study to show a transmission reduction benefit with an antiviral used in the treatment of a respiratory viral illness, according to a release from Genentech. This new data may add to the benefits of Xofluza which is currently approved for treating symptoms and preventing infection following virus exposure. The topline results will be presented at the 2024 OPTIONS XII for the Control of Influenza Congress (Sept 29 to Oct 2 in Brisbane, Australia).
“Building on Xofluza’s established efficacy in treating and preventing influenza after exposure, this new evidence of transmission reduction represents an important advance that could help improve health outcomes at an individual and community level,” says said Levi Garraway, MD, PhD, chief medical officer and head of global product development, in a release. “We look forward to discussing these data with regulatory authorities and public health organizations for influenza pandemic preparedness to bring these benefits to patients.”
Influenza’s Public Health Impact and Xofluza’s Approval
Influenza is one of the most common yet serious infectious diseases representing a significant burden to public health. In the US, since 2010, seasonal influenza has infected up to 41 million people and has caused thousands of hospitalizations and 51,000 deaths annually.
The CENTERSTONE study has been partially supported with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority.
Xofluza is approved in more than 80 countries for the treatment of uncomplicated influenza types A and B. In the US, Xofluza is approved for the treatment of influenza in people 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications, and to prevent influenza in people 5 years of age and older following contact with a person who has the flu (post-exposure prophylaxis).
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