Roche Xofluza bags USFDA okay for influenza treatment in children aged five years and older
Xofluza is available as a one-dose, single-tablet;
Basel: Roche has announced that the United States Food and Drug Administration (USFDA) has approved a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.
"This marks the first single-dose oral influenza medicine approved in the US for children in this age group," the company stated.
Additionally, the USFDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.
"Despite the ongoing COVID-19 pandemic, influenza continues to be a threat to public health, and effective influenza antivirals remain critical to alleviating the burden on healthcare systems," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "Xofluza has proven to be an important tool in fighting and preventing influenza in adults as well as adolescents, and we are pleased to now offer households and younger children our single-dose oral treatment."
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