Genentech Announces FDA Approval of Xofluza (baloxavir marboxil) for People at High Risk of Developing Influenza-Related Complications
South San Francisco, CA -- October 17, 2019 -- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, 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. Xofluza is a first-in-class, one-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.
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