• Xofluxa is a single-dose one-time treatment compared to Tamiflu's twice daily for five day regimen
• In two trials, patients taking Xofluxa had a shorter duration of flu symptoms compared to those taking placebo

On 10/24/18  the FDA approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. The approval was granted to Shionogi & Co., Ltd.

“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. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D.

The safety and efficacy of Xofluza, an antiviral drug taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. In both trials, patients treated with Xofluza had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment.

A phase 3 trial showed that it can effectively kill the flu virus in about 24 hours, while it takes Roche’s popular Tamiflu 72 hours to reach that level of effectiveness. Both Tamiflu and Xofluza require a similar amount of time to completely alleviate symptoms, however, Xofluxa is delivered in a one-time single-dose regimen, while Tamiflu is taken twice daily for five days.