A new DRUG TRIALS SNAPSHOT is now available
Drug Trial Snapshot: XOFLUZA
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the XOFLUZA Package Insert for complete information.
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the XOFLUZA Package Insert for complete information.
XOFLUZA (baloxavir marboxil)
zo-FLEW-zuh
Genentech USA, Inc.
Approval date: October 24, 2018
zo-FLEW-zuh
Genentech USA, Inc.
Approval date: October 24, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
XOFLUZA is a drug to treat the flu (influenza) in people 12 years of age and older who have had flu symptoms for no more than 48 hours.
How is this drug used?
XOFLUZA is a tablet taken as a single dose by mouth within 48 hours of flu symptoms.
The dose depends on the patient’s weight.
What are the benefits of this drug?
Patients treated with XOFLUZA had a shorter time to relieve symptoms compared with patients treated with placebo.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: XOFLUZA worked similarly in males and females.
- Race: XOFLUZA worked similarly among Whites and Asians. The number of patients in other races was limited; therefore, differences in how XOFLUZA worked among other races could not be determined.
- Age: XOFLUZA worked similarly among patients 12 to 17 years of age and those 18 years of age and older.
What are the possible side effects?
The most common side effects are diarrhea, bronchitis, common cold (nasopharyngitis), headache, and nausea
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in males and females.
- Race: The occurrence of side effects was similar in Whites and Asians. The number of patients in other races was limited; therefore, differences in the occurrence of side effects among other races could not be determined.
- Age: The occurrence of side effects among patients 12 to 17 years of age and those older than 18 years of age was similar.
WHO WAS IN THE STUDIES?
Who participated in the clinical trials?
The FDA approved XOFLUZA based on evidence from two clinical trials (Trial 1/1518T0821 and Trial 2/NCT02954354) of 1119 patients with influenza-like illness. Trial 1 was conducted in Japan. Trial 2 was conducted in Japan and the United States.
Demographics of the patients who provided data for evaluation of benefits (efficacy population) are presented in Table 8, under the MORE INFO section.
The population that provided data for side effects of XOFLUZA (safety population) is presented below.
Figure 1 summarizes how many men and women were in the clinical trials used to evaluate safety.
Figure 1. Baseline Demographics by Sex (safety population)
FDA Review
Figure 2 summarizes the percentage of patients by race in the clinical trials used to evaluate safety.
Figure 2. Baseline Demographics by Race
FDA Review
Table 1. Demographics of Efficacy Trials by Race
Race
|
Number of Patients
|
Percentage of Patients
|
|---|---|---|
White
|
296
|
26%
|
Black or African American
|
64
|
6%
|
Asian
|
748
|
67%
|
Other
|
11
|
6%
|
Figure 3 summarizes the percentage of patients by age in the clinical trials used to evaluate safety.
Figure 3. Baseline Demographics by Age
Clinical Trial Data
How were the trials designed?
The benefit and side effects of XOFLUZA were evaluated in two clinical trials in adult and pediatric patients with uncomplicated influenza.
Trial 1 enrolled adult patients 20 to 64 years old who had symptoms of flu for no more than 48 hours. Patients were assigned to receive either a single dose of XOFLUZA or placebo by mouth. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of XOFLUZA was assessed based on the time patients reported all seven symptoms (cough, sore throat, nasal congestion, headache, fever, muscle pain, and tiredness) gone or mild for at least 21.5 hours, comparing the XOFLUZA and placebo groups.
Trial 2 enrolled adult and adolescent patients 12 to 64 years old who had symptoms of flu for not more than 48 hours. Adult patients were assigned to receive either XOFLUZA on Day 1 followed by placebo on Days 2 – 5, placebo as a twice daily dose by mouth for 5 days, or oseltamivir (a medication used to treat and prevent influenza) by mouth twice a day for 5 days. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of XOFLUZA was assessed based on the time patients reported all seven symptoms (cough, sore throat, nasal congestion, headache, fever, muscle pain, and tiredness) gone or mild for at least 21.5 hours, comparing the XOFLUZA and placebo groups.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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