A new DRUG TRIALS SNAPSHOT is now available
Drug Trials Snapshots: AJOVY
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 AJOVY 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 AJOVY Package Insert for complete information.
AJOVY (fremanezumab-vfrm)
Ah-JOE-vee
Teva Pharmaceuticals USA, Inc.
Approval date: September 14, 2018
Ah-JOE-vee
Teva Pharmaceuticals USA, Inc.
Approval date: September 14, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
AJOVY is a drug used for the preventive treatment of migraine in adults.
A migraine is a type of headache that can be associated with nausea, vomiting, and sensitivity to light, sound, or smell.
How is this drug used?
AJOVY is an injection given under the skin (subcutaneous). Two dosing options are available for AJOVY (one subcutaneous injection once a month or three subcutaneous injections once every three months).
What are the benefits of this drug?
Over the three-month treatment period, patients treated with AJOVY experienced fewer days of migraine headaches in comparison to patients who received placebo treatment.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: AJOVY works similarly in both men and women.
- Race: The majority of patients were White. The number of patients in other races were limited; therefore, differences in how AJOVY worked among races could not be determined.
- Age: The majority of patients were less than 65 years of age; therefore, differences in how AJOVY worked among age groups could not be determined.
What are the possible side effects?
AJOVY may cause serious hypersensitivity reactions including rash, itching and hives.
The most common side effect of AJOVY was injection site reactions.
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 majority of patients were White. The number of patients in other races was limited; therefore, differences in side effects among races could not be determined.
- Age: The majority of patients were less than 65 years of age; therefore, differences in side effects among age groups could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved AJOVY based primarily on evidence from two clinical trials, Trial 1/NCT02629861 and Trial 2/NCT02621931, of 1986 patients with chronic or episodic migraine headaches.
Trials were conducted at 255 sites in Canada, Europe, Japan, Israel, and the United States.
Demographics of the patients who provided data for evaluation of side effects (safety population) are presented in Table 7, under the MORE INFO section. The population that provided data for benefits of AJOVY (efficacy population) is presented below.
Figure 1 summarizes how many men and women were enrolled in the clinical trials used to evaluate efficacy.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 summarizes the percentage of patients by race in the clinical trials used to evaluate efficacy.
Figure 2. Baseline Demographics by Race
*Other includes American Indian or Alaska Native, and Native Hawaiian or other Pacific Islander
Clinical Trial Data
Table 1. Demographics of Efficacy Trials by Race
| Race | Number of Patients | Percentage of Patients |
|---|---|---|
| White | 1580 | 80% |
| Black or African American | 180 | 9% |
| Asian | 198 | 10% |
| Other* | 28 | 1% |
*Other includes American Indian or Alaska Native, and Native Hawaiian or other Pacific Islander
Clinical Trial Data
Figure 3 summarizes the percentage of patients by age in the clinical trials used to evaluate efficacy.
Figure 3. Baseline Demographics by Age
Clinical Trial Data
How were the trials designed?
The benefit and side effects of AJOVY were evaluated in two clinical trials of adult patients 18 – 70 years of age with a history of migraine headaches. Each trial was designed differently.
Trial 1 enrolled patients with a history of episodic migraine headaches. Patients were assigned to receive one of two doses of AJOVY or placebo injections over the 3-month treatment period. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of AJOVY was assessed based on the change in the number of migraine days per month during the 3 months treatment period, comparing patients in the AJOVY and placebo groups.
Trial 2 enrolled patients with a history of chronic migraine headaches. Patients were assigned to receive one of two doses of AJOVY or placebo injections over the 3-month treatment period. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of AJOVY was assessed based on the reduction in the number of headache days (of at least moderate severity) from the start of the trial to the last month of treatment, comparing the AJOVY 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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