Shortened Flu Symptoms to 3.0 Days 1

Improvement of flu symptoms in high-risk patients (aged ≥12 years) with XOFLUZA

Single-dose 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 complications. 1


Patients at high risk for developing flu complications experienced 28% faster improvement of flu symptoms with single-dose XOFLUZA compared with placebo. 1

Who Is Considered High Risk? 4-9*

Millions of people in the United States are at high risk for developing flu complications. These risk factors include:

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 Centers for Disease Control and Prevention (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% CI: 67, 85) vs 102 hours (95% CI: 93, 113) with placebo. 1

There was no statistically significant difference in the median time to improvement of influenza symptoms in the subjects who received XOFLUZA (73 hours) and those who received oseltamivir (81 hours). 1

*Not all high-risk factors, as defined by the CDC, were included in Trial 3. 1,4

Other risk factors include Native American or Alaskan Native ancestry, residents of long-term care facilities, neurological/neurodevelopmental conditions, pregnant women and women ≤2 weeks postpartum, metabolic disorders, extreme obesity (body mass index [BMI] ≥40), blood disorders such as sickle cell disease, and persons with immunosuppression. 4

 

Single-dose XOFLUZA can help protect people who have been exposed to the flu by reducing their risk of infection. 1
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XOFLUZA® (baloxavir marboxil) Safety Icon

Safe for Flu Patients

Single-dose XOFLUZA was safe and well tolerated in clinical trials. 1

XOFLUZA® (baloxavir marboxil) Virus Icon

The Flu is Serious

Most people who get the flu recover in 3 to 14 days, but this may not be the case for all patient types. 4,10