Roche (SIX: RO, ROG; OTCQX: RHHBY) 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. This new data may add to the benefits of Xofluza, which is currently approved for treating symptoms and preventing infection following virus exposure.1 The topline results will be presented at the 2024 OPTIONS XII for the Control of Influenza congress (29 September – 2 October, 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,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussing these data with regulatory authorities and public health organisations for influenza pandemic preparedness to bring these benefits to patients.”
Influenza is one of the most common yet serious infectious diseases, representing a significant burden to public health. Every year, seasonal influenza infects an estimated one billion people and causes millions of hospitalisations and up to 650,000 deaths globally. With the co-circulation and burden of multiple respiratory viruses (including COVID-19) infecting individuals within and outside of the winter season, it is more important than ever that influenza is not underestimated. For the effective control of both seasonal and pandemic influenza, early diagnosis and treatment is critical.
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; Biomedical Advanced Research and Development Authority, under Other Transaction Agreement number: HHSO100201800036C.
