A new DRUG TRIALS SNAPSHOT is now available.
VABOMERE is used to treat adults who have a complicated urinary tract infection (abbreviated as cUTI) including infection of the kidneys (pyelonephritis) caused by specific bacteria.
VABOMERE is a combination of two drugs: meropenem a previously-approved drug that fights bacteria and vaborbactam, a new drug that helps meropenem work if the bacteria are resistant to meropenem.
Drug Trials Snapshot: VABOMERE
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that support 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 support 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 VABOMERE 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 the VABOMERE Prescribing Information for complete information.
VABOMERE (meropenem and vaborbactam)
(VAY boh meer)
The Medicines Company
Approval date: August 29, 2017
(VAY boh meer)
The Medicines Company
Approval date: August 29, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
VABOMERE is used to treat adults who have a complicated urinary tract infection (abbreviated as cUTI) including infection of the kidneys (pyelonephritis) caused by specific bacteria.
VABOMERE is a combination of two drugs: meropenem a previously-approved drug that fights bacteria and vaborbactam, a new drug that helps meropenem work if the bacteria are resistant to meropenem.
VABOMERE is a combination of two drugs: meropenem a previously-approved drug that fights bacteria and vaborbactam, a new drug that helps meropenem work if the bacteria are resistant to meropenem.
How is this drug used?
VABOMERE is a drug administered by a health care professional directly into the bloodstream through a needle in the vein. This is known as an intravenous, or IV, infusion. It is given every 8 hours for up to 14 days.
What are the benefits of this drug?
After receiving IV treatment with VABOMERE, 98% of patients cured or improved signs and symptoms of cUTI and decreased the number of bacteria in urine in comparison to 94% of patients who received another antibacterial drug piperacillin-tazobactam.
Because cUTI can come back, patients continued with oral antibacterial drugs to complete the treatment for cUTI. The benefit was also evaluated after this treatment was completed (about one week later) and it showed that 76% of patients who were initially treated with VABOMERE and 73% of patients who were initially treated with piperacillin-tazobactam were cured from cUTI.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: VABOMERE worked similarly in men and women.
- Race: The majority of patients were White. The number of patients in other races was limited. Differences in how well the drug worked among races could not be determined.
- Age: VABOMERE worked similarly in patients below and above 65 years of age.
What are the possible side effects?
VABOMERE can cause serious and life threatening allergic reactions. Other serious side effects include seizures and severe diarrhea caused by C. difficile.
Common side effects that were associated with the use of VABOMERE include headache, infusion site reactions, and diarrhea.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar between men and women.
- Race: The majority of patients were White. The number of patients in other races was limited. Differences in side effects among races could not be determined.
- 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?
FDA approved VABOMERE based on the trial (NCT02166476) of 545 patients with cUTI. The trial included patients from the Europe, North America, Asia and South America.
Figure 1 summarizes how many men and women were in the clinical trial.
Figure 1. Baseline Demographics by Sex
FDA Clinical review
Figure 2 and Table 1 summarize the percentage of patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race
FDA Clinical review
Table 1. Baseline Demographics by Race
Race | Number of Patients | Percentage (%) |
|---|---|---|
White | 506 | 93 |
Black / African American | 7 | 1 |
Asian | 10 | 2 |
Other | 22 | 4 |
FDA Clinical review
Figure 3 summarizes by age how many patients were in the clinical trial
Figure 3. Baseline Demographics by Age
How were the trials designed?
In the clinical trial, half of the patients were chosen at random to receive VABOMERE, and the other half was given another antibacterial drug called piperacillin-tazobactam. Both treatments were given intravenously every 8 hours for up to 14 days and neither the patients nor the health care professionals knew which drugs were given until after the study was complete. After 5 days of IV treatment with VABOMERE or piperacillin-tazobactam, patients could be switched to other oral antibacterial drugs to complete the treatment for cUTI.
The benefit of VABOMERE was measured by the proportion of patients who achieved cure or improvement in their symptoms related to cUTI and a negative urine culture test and compared it to piperacillin-tazobactam.
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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