On Thursday, Roche Holdings AG RHHBY released positive topline results of the phase 3 CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral that showed 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.
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Xofluza was well tolerated, and no new safety signals were identified.
CENTERSTONE is the first global phase 3 study to show a transmission reduction benefit with an antiviral used to treat 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.
"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 organizations for influenza pandemic preparedness to bring these benefits to patients."
Influenza is one of the most common yet serious infectious diseases. Every year, seasonal influenza infects an estimated one billion people and causes millions of hospitalizations and up to 650,000 deaths globally.
Federal funds from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority have partially supported the CENTERSTONE study.
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