FDA Approves New Drug to Treat Flu

The U.S. Food and Drug Administration announced the approval of Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated flu. The drug, made by Genentech, has been approved for use in patients 12 and older who have been symptomatic for no longer than 48 hours.

This is the first new antiviral flu treatment approved in nearly two decades. Xofluza is a single-dose oral medication with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. The safety and efficacy of the drug was demonstrated in two randomized controlled clinical trials of 1,832 patients in which participants were either assigned to receive Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. Xofluza was shown to reduce the duration of flu symptoms compared to placebo. In the second trial, no difference in time to alleviation of symptoms was shown between subjects who received Xofluza and those who received the other flu treatment.  The drug has demonstrated efficacy against several influenza viruses including oseltamivir-resistant strains and avian strains (H7N9 and H5N1) in non-clinical studies.

Read about the IDSA Foundation’s public education campaign focused on dispelling common myths about the flu and join the conversation on social media with the hashtag #CureConFLUsion.