Posted by Michael Wonder on 17 Oct 2019
Genentech announces FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications
17 October 2019 - Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from influenza.
Genentech today announced that the U.S. FDA has approved a supplemental new drug application 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.
This expanded indication for Xofluza was approved based on results from the Phase III CAPSTONE-2 study of a single dose of 40 mg or 80 mg of Xofluza compared to oseltamivir (75 mg twice daily for five days), or placebo in people 12 years of age or older who met CDC criteria for being at high risk of complications from the flu.
