Xofluza (baloxavir marboxil)
Xofluza is a single-dose oral medicine with a novel proposed mechanism of action that has demonstrated efficacy against a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies. Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.
Xofluza is approved in the US for the treatment of acute uncomplicated influenza and patients at high risk of developing influenza complications. Xofluza is also approved for acute uncomplicated influenza in 27 other countries including Japan, Switzerland, Canada, Australia and South Korea, and is currently under review by the EMA.
Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialised globally in collaboration with the Roche Group (which includes Genentech in the US) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, where rights will be retained exclusively by Shionogi & Co., Ltd.