Roche gets European Commission nod for Xofluza to treat influenza in children aged one year and above
Influenza is a serious infectious disease and represents a significant threat to public health.;
Basel: Roche has announced that the European Commission (EC) has approved Xofluza (baloxavir marboxil) in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza.
Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. The Commission’s Decision is based on the results of the phase III miniSTONE-2 and BLOCKSTONE studies.
"This approval marks the first single-dose, oral influenza medicine approved in Europe for children, and now means that Xofluza can be used to treat and prevent uncomplicated influenza in children aged one year and above, and in adolescents and adults," the release sted.
“We are delighted that the European Commission has approved Xofluza for children aged one year and above, as influenza can be particularly dangerous for younger children,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are hopeful that Xofluza’s convenient single-dose oral regimen will help children recover quickly, as well as reduce the societal burden of influenza.”
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