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Drug Trials Snapshots: EXBLIFEP

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic 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 healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the EXBLIFEP Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

EXBLIFEP (cefepime and enmetazobactam)
EX-BLEE-FEP
Allecra Therapeutics SAS 
Original Approval date: February 22, 2024


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

EXBLIFEP is a combination of cefepime and enmetazobactam that is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible microorganisms.

How is this drug used?

EXBLIFEP is administered as an intravenous (IV) infusion every eight hours for 7 days, or up to 14 days for patients with concurrent bacteremia.

Who participated in the clinical trials?

The FDA approved EXBLIFEP based on evidence from a clinical trial of 1,041 patients (intent-to-treat population) with cUTI, including pyelonephritis. The trial was conducted at 90 sites in 19 countries including Argentina, Bulgaria, Belarus, Spain, Estonia, Georgia, Croatia, Hungary, Lithuania, Latvia, Mexico, Peru, Poland, Russia, Serbia, Slovakia, South Africa, Ukraine, and the United States. All but one subject were enrolled outside of the United States.

How were the trials designed?

EXBLIFEP was evaluated in a multinational, double-blind, noninferiority clinical trial of 1,041 patients with cUTI, including pyelonephritis.

Patients were randomized in a 1:1 ratio into one of the two treatment groups, EXBLIFEP and piperacillin/tazobactam. The medications were intravenously infused over a period of two hours, every eight hours for 7 days, or up to 14 days for patients with concurrent bacteremia. The primary efficacy endpoint was a composite endpoint of clinical cure and microbiological response, at the test of cure (TOC) visit (seven days after the end of treatment).

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many male and female patients were included in the clinical trial used to evaluate the efficacy of EXBLIFEP.

Figure 1. Baseline Demographics by Sex (Primary Efficacy Population)

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 271 (40%) male patients and 407 (60%) female patients participated in the clinical trial.
Source: Adapted from FDA Review

Figure 2 summarizes how many patients by race in the clinical trial used to evaluate the efficacy of EXBLIFEP.

Figure 2. Baseline Demographics by Race (Primary Efficacy Population)

Pie chart summarizing how many White, Black or African American, Asian or Pacific Islander, and other patients were in the clinical trial. In total, 643 (94.8%) White patients, 1 (0.1%) Black or African American patient, 4 (0.6%) Asian or Pacific Islander patients, and 30 (4.4%) other patients participated in the clinical trial.
Source: Adapted from FDA Review

Figure 3 summarizes how many patients by age included in the clinical trial used to evaluate the efficacy of EXBLIFEP.

Figure 3. Baseline Demographics by Age (Primary Efficacy Population) 

Pie chart summarizing how many patients by age were in the clinical trial. In total, 3 (0.4%) patients younger than 18 years of age, 439 (64.7%) patients between 18 and 65 years of age, and 236 (34.8%) patients older than 65 years of age participated in the clinical trial.
Source: Adapted from FDA Review

Figure 4 summarizes how many patients by ethnicity included in the clinical trial used to evaluate the efficacy of EXBLIFEP.

Figure 4. Baseline Demographics by Ethnicity (Primary Efficacy Population)

Pie chart summarizing how many Hispanic, not Hispanic, and unknown patients were in the clinical trial. In total, 53 (7.8%) Hispanic or Latino patients, 623 (91.9%) not Hispanic or Latino patients, and 2 (0.3%) other patients participated in the clinical trial.
Source: Adapted from FDA Review

What are the benefits of this drug? 

Clinical trial evidence from the single controlled study demonstrates that EXBLIFEP was noninferior to piperacillin/tazobactam. Composite response was achieved in 273/345 (79%) patients in the EXBLIFEP group and 196/333 (59%) patients in the piperacillin/tazobactam group at the TOC visit in the m-MITT population.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

  • Sex: EXBLIFEP worked similarly in males and females.
  • Race:  The number of patients of races other than White was small; therefore, differences in how EXBLIFEP worked among races could not be determined.
  • Age: EXBLIFEP worked similarly in patients in all age groups.

What are the possible side effects?

EXBLIFEP may cause serious allergic reactions, neurological adverse reactions, and severe diarrhea caused by Clostridioides difficile.

Common side effects that were associated with the use of EXBLIFEP include abnormal liver tests, headache, and phlebitis/infusion site reactions.

Were there any differences in side effects among sex, race, and age?

  • Sex: The occurrence of side effects was similar between males and females.
  • Race: The number of participants of races other than White was small; therefore, differences in side effects among races could not be determined
  • Age: The occurrence of side effects was similar in patients younger and older than 65 years of age.

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 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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