Shionogi's Xofluza approved in Taiwan

Japanese drug major Shionogi (TYO: 4507) says that in-house discovered Xofluza (baloxavir marboxil) was approved in Taiwan for the treatment of acute influenza Types A and B in patients 12 years of age and older on August 28, 2019.

Xofluza, which was approved in Japan in February 2018 and in the USA in October that year, has a novel mechanism of action that inhibits cap-dependent endonuclease, an essential enzyme for viral replication. Support for this approval includes clinical efficacy and safety data from a Phase II study in Japan, a global phase III study (CAPSTONE-1) in otherwise healthy patients, and a global phase III study (CAPSTONE-2) in individuals at high risk for influenza-related complications.

Subsidiary Taiwan Shionogi & Co will launch Xofluza in Taiwan, and will provide scientific information on the drug’s novel mechanism of action, its unique single oral dosing regimen, as well as its effects on the virus, including PA/I38X-substituted viruses with reduced susceptibility to Xofluza.