Proven results based on 2 pivotal clinical trials 1

1-dose XOFLUZA was compared with placebo in phase 2, and placebo and oseltamivir in phase 3. Both trials were multicenter, randomized, double-blind studies that evaluated efficacy and safety in subjects in the United States and Japan. The primary endpoint of both trials was median time to alleviation of symptoms (TTAS) compared to placebo.

XOFLUZA can help your patients feel better, faster—by shortening flu symptoms to just 2.3 days 1

In the primary endpoint in Trial 2, 1-dose XOFLUZA reduced duration of flu symptoms to just 2.3 days compared with 3.3 days with placebo. 1

In Trial 1, conducted in Japan, subjects aged 20-64 years received XOFLUZA 40 mg (n=100) or placebo (n=100). The median value of the primary endpoint of TTAS with XOFLUZA was 50 hours (95% confidence interval [CI]: 45, 64) vs 78 hours (95% CI: 68, 89) with placebo (p=0.014). In Trial 2, conducted in US and Japan, subjects aged 12-19 years received either XOFLUZA (n=80) or placebo (n=38); subjects aged 20-64 years received either XOFLUZA (n=375), oseltamivir 12 (n=377), or placebo (n=192). In total, 455 subjects were treated with XOFLUZA, 230 with placebo, and 377 with oseltamivir. In subjects aged 12-64 years, the median value of the primary endpoint of TTAS with XOFLUZA was 54 hours (95% CI: 50, 59) vs 80 hours (95% CI: 73, 87) with placebo (p<0.001). TTAS in both Trial 1 and Trial 2 was defined as the time when all of 7 symptoms (cough, sore throat, nasal congestion, headache, feverishness, myalgia, and fatigue) had been assessed by the subject as none or mild for a duration of at least 21.5 hours.

In a secondary endpoint in Trial 2, in subjects 20-64 years of age, reduction of duration of flu symptoms was similar with XOFLUZA compared with oseltamivir. 1

In adolescent subjects, XOFLUZA shortened flu symptoms 42% faster

In Trial 2, for subjects aged 12-17 years, time to symptom alleviation was achieved 39 hours faster with XOFLUZA (n=63) when compared to placebo (n=27) (median time of 54 h [95% CI: 43, 81] vs 93 h [95% CI: 64, 118]). 1

The first and only 1-dose oral antiviral

XOFLUZA is just 1 dose—keeping your patients on track to be over and done with the flu. 1

Stop viral replication

XOFLUZA works differently by targeting the flu at its source to stop viral replication.1

XOFLUZA safety profile

XOFLUZA was as safe and well-tolerated as placebo in clinical trials. 1