It is a first-in-class, single-dose oral medicine with an innovative mechanism of action that has demonstrated efficacy among several influenza viruses, including in vitro activity against oseltamivir-resistant and avian strains (H7N9, H5N1) in nonclinical studies. Xofluza is designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication and approved in >70 countries for treating influenza types A and B.
Xofluza was discovered by Shionogi and is being further developed and commercialised globally in collaboration with the Roche Group (including Genentech in the US) and Shionogi & Co.. Under this agreement, Roche holds worldwide rights of Xofluza, excluding Japan and Taiwan, which will be retained exclusively by Shionogi. Moreover, the Roche Group is preparing to apply for an expansion of the indication to include <1-year-old children.