Roche's Xofluza Gains Expanded Paediatric Approval in China for Influenza

Roche's antiviral therapy Xofluza (baloxavir marboxil) has received an expanded label in China, now approved for the treatment of influenza in children as young as 1 year old. The approval covers both the tablet and dry suspension formulations, extending treatment access from previously age 5 and above down to age 1 and above. This makes Xofluza the first single-dose oral antiviral available for this very young paediatric population in the country.

The expanded approvals are supported by two Phase III studies, MINISTONE-2 and DRAGONSTONE, which demonstrated that Xofluza was well-tolerated and effective in children aged 1 to under 12 years. Compared to the neuraminidase inhibitor oseltamivir, Xofluza significantly shortened the duration of viral shedding.

PharmCube's NextBiopharm® database shows that Roche continues to develop the treatment in COVID-19. Click here to request a free trial for NextBiopharm®.

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