Yesterday the U.S. Food and Drug Administration approved Xofluza (balorxavir marhboxil), a new influenza treatment for acute uncomplicated influenza in people age 12 and older who have been symptomatic for no more than 2 days. This new drug, developed by Genentech, the same company who developed Tamiflu in 1999, is a single-dose selective inhibitor cap-dependent endonuclease.
FDA Commissioner Scott Gottlieb, MD says “This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical.” The FDA emphasizes the importance to encourage patients to get their yearly flu vaccination by the end of October to prevent the spread of influenza during the 2018 Flu Season.
Xofluza will be open to the market within the next few weeks. According to a report published in the New England Journal of Medicine, Baloxavir marboxil was more effective than the placebo and oseltamivir (the generic Tamiflu) in reducing the viral load after only 1 day. See the study here.