Phase III Study Confirms Xofluza Significantly Reduces Influenza Virus Transmission

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral medication, demonstrating a significant reduction in the transmission of influenza viruses. The study successfully met its primary endpoint, showing that a single oral dose of Xofluza taken by individuals infected with influenza significantly lowered the risk of household members contracting the virus. Xofluza was well tolerated, with no new safety concerns identified.

CENTERSTONE is the first global phase III study to show that an antiviral used to treat a respiratory viral illness can reduce transmission. This new data further supports the benefits of Xofluza, which is already approved for treating flu symptoms and preventing infection after exposure. The topline results will be presented at the 2024 OPTIONS XII for the Control of Influenza congress, held from 29 September to 2 October in Brisbane, Australia.

“Building on Xofluza’s established efficacy in treating and preventing influenza post-exposure, this new evidence of transmission reduction marks a significant advancement that could improve health outcomes at both individual and community levels,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to engaging with regulatory authorities and public health organizations for influenza pandemic preparedness to bring these benefits to patients.”

Influenza remains one of the most common but serious infectious diseases, posing a major public health challenge. Each year, seasonal influenza infects approximately one billion people, leading to millions of hospitalizations and up to 650,000 deaths globally. With the ongoing circulation of multiple respiratory viruses, including COVID-19, it is critical not to underestimate the impact of influenza. Early diagnosis and treatment are key to effectively controlling both seasonal and pandemic influenza.

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