Genentech’s Xofluza Reduces Flu Transmission in Landmark Phase III Study

Genentech, a Roche Group company, announced successful results from the global Phase III CENTERSTONE study, which revealed that Xofluza® (baloxavir marboxil), an antiviral drug, significantly reduced the transmission of influenza from infected individuals to their household members. The study, involving over 4,000 participants across 272 sites worldwide, met its primary endpoint by demonstrating that a single oral dose of Xofluza taken within 48 hours of symptom onset lowered the chances of household contacts contracting the virus. Xofluza was well tolerated, and no new safety concerns emerged.

This marks the first time an antiviral for a respiratory illness has shown a transmission reduction benefit in a global Phase III trial, positioning Xofluza as a key player in mitigating both seasonal and pandemic influenza outbreaks. The study’s results will be presented at the 2024 OPTIONS XII for the Control of Influenza Congress in Brisbane, Australia.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, emphasized that reducing the spread of influenza within households can have broader community health benefits, particularly in light of co-circulating viruses like COVID-19. Genentech plans to discuss the results with regulatory authorities and public health organizations to explore further uses of Xofluza in pandemic preparedness.

Influenza remains a serious public health concern, infecting millions and causing significant mortality worldwide each year. The addition of Xofluza's transmission-reducing capabilities could help alleviate the burden on healthcare systems, especially during flu season.

Xofluza, approved in over 80 countries, is a first-in-class, single-dose antiviral that inhibits viral replication and is used to treat and prevent influenza in individuals aged five and older. Developed by Shionogi & Co., Ltd., Xofluza is globally commercialized in collaboration with the Roche Group.