BRIEF—Shionogi gains approval of Xofluza in Taiwan for children

Japanese pharma major Shionogi has received approval of a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for the treatment and post-exposure prophylaxis for influenza virus infection for pediatrics aged 5 to <12 years in Taiwan.

Xofluza is available for adults and children of ≥12 years of age for treating influenza A or B virus acute infection and the postexposure prophylaxis of influenza in Taiwan.

The newly approved indication extends the option for treating and preventing influenza virus infections to children aged 5 to <12 years, who weigh >20 kg, offering a new choice for managing influenza.

Xofluza was discovered by Shionogi and is being further developed and commercialized globally in collaboration with Swiss pharma giant Roche Group (including Genentech in the USA) and Shionogi.

The Roche Group is preparing to apply for an expansion of the indication to include <1-year-old children.