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Drug Trials Snapshots: FASENRA
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 FASENRA Prescribing Information 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 FASENRA Prescribing Information for complete information.
FASENRA (benralizumab)
fas-en-rah
AstraZeneca
Approval date: November 14, 2017
fas-en-rah
AstraZeneca
Approval date: November 14, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
FASENRA is a drug for the treatment of specific type of severe asthma (called eosinophilic phenotype asthma) in patients 12 years and older whose asthma is not well controlled with current medications. FASENRA is to be used in addition to asthma maintenance medications.
How is this drug used?
FASENRA is given by a healthcare provider using a needle placed under the skin one time every 4 weeks for the first 3 doses, and then every 8 weeks.
What are the benefits of this drug?
Patients who received FASENRA had fewer asthma attacks that required a stay in the hospital and/or a visit to the emergency room, and had greater reduction in their daily maintenance dose of oral corticosteroids.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: FASENRA worked similarly in men and women.
- Race: FASENRA worked similarly among races studied.
- Age: FASENRA worked similarly in patients below and above 65 years of age.
What are the possible side effects?
FASENRA may cause severe allergic reactions including a life threatening allergic reaction called anaphylaxis.
The most common side effect of FASENRA are headache and sore throat.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in men and women.
- Race: The occurrence of side effects was similar among races studied.
- Age: The occurrence of side effects was similar in patients below and above 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved FASENRA based on the evidence from three clinical trials (Trial 1 [NCT01928771], Trial 2 [NCT01914757], Trial 3 [NCT02075255]) of 1817 patients with severe asthma. The trials were conducted in the USA, Canada, South America, Europe, Asia and Africa.
The figure below summarizes how many men and women were in the clinical trials.
Figure 1. Baseline Demographics by Sex
FDA review
Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trials.
Figure 2. Baseline Demographics by Race
FDA review
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 1449 | 80 |
| Black or African American | 62 | 3 |
| Asian | 217 | 12 |
| American Indian or Alaskan Native | 22 | 1 |
| Native Hawaiian or Pacific Islander | 2 | less than 1 |
| Other | 65 | 4 |
FDA review
Figure 3 summarizes the percentage of patients by age in the clinical trials.
Figure 3. Baseline Demographics by Age
FDA review
How were the trials designed?
The benefit and side effects of FASENRA were evaluated in three clinical trials of patients with severe asthma and increased eosinophilic white cells in blood. All patients were taking their usual treatments for asthma. In addition, patients received new treatment with either FASENRA or placebo. Neither the patients nor the health care providers knew which new treatment was being given until after the trials were completed.
In the first two trials the benefit of FASENRA was evaluated by measuring the frequency of asthma attacks (exacerbations) in comparison to placebo, and in the third trial by measuring the use of maintenance corticosteroids in comparison to placebo.
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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