Proven efficacy across a broad range of flu patients

In clinical trials, just a single dose of XOFLUZA demonstrated efficacy in both otherwise healthy and high-risk flu patients. 1

XOFLUZA shortened flu symptoms to 2.3 days in otherwise healthy patients

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 time to alleviation of symptoms (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 (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. 1,19

In a secondary endpoint in Trial 2, in subjects ≥20 years of age, reduction of duration of flu symptoms was 54 hours for both XOFLUZA and 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 (1.6 days) 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

XOFLUZA improved flu symptoms in 3 days in high-risk patients

  • XOFLUZA is the first oral antiviral to demonstrate improvement in flu symptoms over placebo in a clinical study of patients at high risk of developing flu-related complications 1

In Trial 3, subjects aged ≥12 years (n=2182) were randomized to receive XOFLUZA 40 mg or 80 mg according to body weight (n=729), oseltamivir 75 mg twice daily for 5 days (n=725) or placebo (n=728). High-risk factors were based on the CDC definition of health factors known to increase the risk of developing serious complications from influenza, including underlying asthma or chronic lung disease, diabetes, heart disease, morbid obesity, or ≥65 years of age. The primary efficacy endpoint was time to improvement of influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue). This endpoint included alleviation of new symptoms and improvement of any preexisting symptoms that had worsened due to influenza. The median value of the primary endpoint of time to improvement of symptoms (TTIS) with XOFLUZA was 73 hours (95% confidence interval [CI]: 67, 85) vs 102 hours (95% CI: 93, 113) with placebo (P<0.001). 1

In a secondary endpoint in the high-risk study (Trial 3), reduction in median time to improvement of symptoms was 73 hours with XOFLUZA compared to 81 hours with oseltamivir. 1

*Not all high-risk factors, as defined by the CDC, were included in Trial 3.
Not statistically significant.

Just a single dose

XOFLUZA keeps your patients on track to be done with the flu with just a single dose. 1

Safe as placebo in clinical trials

XOFLUZA was as safe and well tolerated as placebo in clinical trials, even among high-risk patients. 1