A new DRUG TRIALS SNAPSHOT is now available
Drug Trials Snapshots: TAKHZYRO
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 TAKHZYRO 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 TAKHZYRO Package Insert for complete information.
TAKHZYRO (lanadelumab-flyo)
tak-ZYE-roe
Dyax Corp.
Approval date: August 23,2018
tak-ZYE-roe
Dyax Corp.
Approval date: August 23,2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
TAKHZYRO is a drug used to prevent attacks of hereditary angioedema in people 12 years and older.
Hereditary angioedema is a rare, inherited and sometimes life-threatening condition with repeat episodes (attacks) of severe swelling in various parts of the body, including stomach, limbs, face and throat.
How is this drug used?
TAKHZYRO is injected under the skin every two weeks.
What are the benefits of this drug?
Patients who received TAKHZYRO had fewer angioedema attacks compared to those receiving the placebo.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: TAKHZYRO worked similarly in males and females.
- Race: The majority of patients was White. The number of patients of other races was limited; therefore, differences in response among races could not be determined.
- Age: The majority of patients was less than 65 years of age. The number of patients 65 years and older was limited; therefore, differences in response among age groups could not be determined.
What are the possible side effects?
TAKHZYRO may cause serious allergic reactions.
The most common side effects of TAKHZYRO are injection site reactions, upper respiratory infections, headache, rash, muscle pain, dizziness, and diarrhea.
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 majority of patients was White. The number of patients of other races was limited; therefore, differences in the occurrence of side effects among races could not be determined.
- Age: The majority of patients was less than 65 years of age. The number of patients 65 years and older was limited; therefore, differences in the occurrence of side effects among age groups could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved TAKHZYRO based on evidence from one clinical trial (Trial 1 /NCT02586805) of 125 patients with hereditary angioedema. The trial was conducted at 41 sites in Canada, Europe, Jordan, and the United States.
Figure 1 summarizes how many males and females were in the clinical trial used to evaluate safety and efficacy.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 summarizes the percentage of patients by race in the clinical trial used to evaluate safety and efficacy.
Figure 2. Baseline Demographics by Race
FDA Review
Table 1. Demographics of Trial 1 by Race
| Race | Number of Patients | Percentage of Patients |
|---|---|---|
| White | 113 | 90% |
| Black or African American | 10 | 8% |
| Asian | 2 | 2% |
FDA Review
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
The benefit and side effects of TAKHZYRO were evaluated in one clinical trial. Trial investigators observed patients 12 years and older with hereditary angioedema (HAE) to determine the number of attacks for each patient. The trial enrolled patients with at least 1 attack during the 4-week period. Patients were assigned to receive one of three doses of TAKHZYRO once every 2 or 4 weeks, or placebo once every 2 weeks for 26 weeks. Neither the patients nor the investigators knew which treatment was being given until after the trial was completed. All patients could use other medications for treatment of acute attacks.
Trial investigators recorded the number of angioedema attacks in all treated groups over the 26 weeks. The benefit of TAKHZYRO was assessed by comparing the reduction rate of HAE attacks to placebo over a 26-week treatment period.
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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