Exblifep FDA Approval History
Last updated by Judith Stewart, BPharm on March 12, 2024.
FDA Approved: Yes (First approved February 22, 2024)
Brand name: Exblifep
Generic name: cefepime and enmetazobactam
Dosage form: Injection
Company: Allecra Therapeutics
Treatment for: Urinary Tract Infection
Exblifep (cefepime and enmetazobactam) is a fourth generation cephalosporin and beta lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).
- Exblifep is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Exblifep and other antibacterial drugs, Exblifep should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. - A simple UTI (or simple cystitis) is an infection of the urinary tract typically seen in afebrile, non-pregnant, immune-competent female patients. A complicated UTI is any UTI other than a simple UTI and includes UTIs in immunocompromised patients, males, pregnant patients, and those associated with fevers, stones, sepsis, urinary obstruction, catheters, or involving the kidneys.
- Exblifep is designed to combat anti-microbial resistance in gram-negative bacteria, especially resistance mediated by Extended Spectrum Beta Lactamases (or ESBLs).
- FDA approval of Exblifep was supported by clinical data that demonstrated Exblifep's effectiveness against antimicrobial resistance in gram-negative bacteria, especially resistance mediated by both ESBL (Extended Spectrum Beta Lactamases) and AmpC. This included results from Allecra’s Phase 3 ALLIUM trial, which met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary composite outcome of clinical cure and microbiological eradication in patients with cUTIs.
- Exblifep is administered by intravenous infusion over 2 hours, every 8 hours for 7 days to 14 days.
- Warnings and preacautions associated with Exblifep include hypersensitivity reactions, neurotoxicity, and clostridioides difficile-associated diarrhea.
- Common adverse reactions include increased transaminases, increased bilirubin, headache, and phlebitis/infusion site reactions.
Development timeline for Exblifep
Further information
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