Genentech’s Xofluza bags FDA approval for flu complications

Genentech’s Xofluza (baloxavir marboxil) has been granted US Food and Drug Administration (FDA) approval for a supplemental New Drug Application (NDA). The approval has been approved for the indication of acute, uncomplicated influenza, or flu, in people 12 and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. The approval marks the drug as the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from the flu, and was approved based on results from the Phase III CAPSTONE-2 study, which included people 12 years and older who met the CDC criteria for being at high risk of complications from the flu.

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