Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older

Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of ageThe FDA also approved Xofluza to prevent influenza in children aged five years and older following contact with an infected personBasel, 12 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (U.S.) Food and Drug Administration (FDA) 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 gr oup. Additionally, the FDA 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 Developmen t. “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 ...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news