Roche Holding AG's Xofluza gained expanded approval from the U.S. Food and Drug Administration to treat people at high risk of developing complications from influenza.
The Centers for Disease Control and Prevention categorizes high-risk patients as those who are 65 years and older or who have health conditions such as asthma, chronic lung disease, diabetes or heart disease.
Xofluza, or baloxavir marboxil, received the regulatory approval to treat acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications.
The FDA's approval is based on results from a late-stage study, called Capstone-2, which showed that the drug was better than Tamiflu and placebo at reducing flu symptoms in the high-risk population.
Xofluza was initially approved by the FDA in October 2018 to treat acute, uncomplicated flu in otherwise healthy people 12 years of age and older who have been symptomatic for no more than 48 hours.
The flu drug was discovered by Osaka-based Shionogi & Co. Ltd. and is being further developed and commercialized in collaboration with Roche, which holds worldwide rights to Xofluza excluding Japan and Taiwan.