Exblifep (cefepime/enmetazobactam) / Allecra - LARVOL DELTA

Understanding Pharmacokinetic-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2024 to Better Manage the Risk of Drug Interactions With Concomitant Medications: A Review of Clinical Data From New Drug Applications. (PubMed, Curr Ther Res Clin Exp) - "Of these, 7 drugs were substrates of CYP3A, 3 of CYP2C9, one of CYP1A2, and one of CYP2C8, including the sensitive substrates vanzacaftor (CYP3A) and vorasidenib (CYP1A2). As precipitants, 6 drugs (acoramidis, cefepime/enmetazobactam, givinostat, lazertinib, mavorixafor, and resmetirom) were clinical inhibitors of CYP enzymes (2C8, 2C9, 2D6, 2E1, and 3A), with mavorixafor being a CYP2D6 strong inhibitor. Two drugs (elafibranor and tovorafenib) showed weak induction of CYP3A. Regarding transporter data, 3 drugs were substrates of transporters, including seladelpar (BCRP and OAT3), sulopenem (OAT3), and vadadustat (OAT1/3), and 8 drugs (arimoclomol, danicopan, givinostat, lazertinib, mavorixafor, resmetirom, vadadustat, and vazacaftor/tezacaftor/deutivacaftor) were inhibitors of transporters...Several DDIs with an AUC change <2 also had labeling recommendations, pertaining most often to the concomitant use of drugs with a narrow therapeutic index. Mechanistic DDI..."

Clinical data • FDA event • Journal • NDA • PK/PD data • Review • CYP1A2 • CYP2C9

Synergy evaluation of cefepime/enmetazobactam in combination with novel β-lactam/β-lactamase inhibitor combinations (βL/βLICs) against Klebsiella pneumoniae carrying different blaKPC variants. (PubMed, J Antibiot (Tokyo)) - No abstract available

Journal • Infectious Disease • Pneumonia

Domiciliary use of cefepime/enmetazobactam in a portable infusion pump: a pioneering experience (ESCMID Global 2026) - No abstract available

In vitro activity of cefepime/enmetazobactam vs meropenem against Enterobacterales producing blaOXA-48-like carbapenemase and blaCTX-M extended-spectrum β-lactamase (ESCMID Global 2026) - No abstract available

Preclinical

Cefepime/enmetazobactam: a powerful carbapenem-sparing option against ESBL and IRT producers (ESCMID Global 2026) - No abstract available

In vitro activity of cefepime/enmetazobactam vs ceftazidime/avibactam against ESBL and OXA-48 Enterobacterales (ESCMID Global 2026) - No abstract available

Preclinical

Role of OmpK36 in cefepime/enmetazobactam resistance in KPC-producing K. pneumoniae (ESCMID Global 2026) - No abstract available

Infectious Disease • Pneumonia

Effectiveness of cefepime/enmetazobactam against highly multidrug-resistant bacterial isolates recovered from war-associated wounds in Ukraine (ESCMID Global 2026) - No abstract available

Pharmacokinetics of cefepime/enmetazobactam in the cerebrospinal fluid of rats (ESCMID Global 2026) - No abstract available

PK/PD data • Preclinical

Dynamic assessment of cefepime/enmetazobactam concentrations in medulla spinalis, the subarachnoid and epidural space: an experimental porcine study (ESCMID Global 2026) - No abstract available

Preclinical

Real world compassionate use of cefepime/enmetazobactam for infections caused by Enterobacterales: a multi-centre observational study (ESCMID Global 2026) - No abstract available

Clinical • Observational data • Real-world • Real-world evidence • Infectious Disease

Cefepime/enmetazobactam as a carbapenem-sparing option for urinary tract infections: in vitro time-kill activity against ESBL-producing Klebsiella pneumoniae (ESCMID Global 2026) - No abstract available

Preclinical • Infectious Disease • Nephrology • Pneumonia

In vitro activity of cefepime/enmetazobactam against OXA-48-producing Enterobacterales: findings from a single-centre retrospective study (ESCMID Global 2026) - No abstract available

Preclinical • Retrospective data

Impact of inoculum effect on in vitro activity of cefepime-enmetazobactam against ESBL-producing Escherichia coli (ESCMID Global 2026) - No abstract available

Preclinical

In vitro activity of cefepime/enmetazobactam against genomically characterised ESBL-producing Enterobacterales from a high endemicity setting (ESCMID Global 2026) - No abstract available

Preclinical

In vitro activity of cefepime/enmetazobactam and cefepime/zidebactam against OXA-48-like producing Klebsiella pneumoniae clinical strains (ESCMID Global 2026) - No abstract available

Preclinical • Infectious Disease • Pneumonia

Impact of inoculum size on the in vitro bactericidal activity of cefepime/enmetazobactam against ESBL-producing Klebsiella pneumoniae isolates (ESCMID Global 2026) - No abstract available

Preclinical • Infectious Disease • Pneumonia

Overview of adverse events in patients with acute pyelonephritis treated with cefepime/enmetazobactam vs piperacillin/tazobactam: a post-hoc analysis from the ALLIUM phase III trial (ESCMID Global 2026) - No abstract available

Adverse events • Clinical • P3 data • Retrospective data • Nephrology

Potential role of cefepime/enmetazobactam as an alternative therapy during an OXA-48 and ESBL-producing Klebsiella pneumoniae outbreak in an onco-haematology unit (ESCMID Global 2026) - No abstract available

Hematological Disorders • Infectious Disease • Pneumonia

Overall response and microbiological eradication of cefepime/enmetazobactam vs piperacillin/tazobactam in patients with acute pyelonephritis: a post-hoc analysis from the ALLIUM phase III trial (ESCMID Global 2026) - No abstract available

Clinical • P3 data • Retrospective data • Nephrology

IS13 - The AMR puzzle: solving MDR Enterobacterales with the new BL/BLI combinations (ESCMID Global 2026) - "Organised by ADVANZ PHARMA The aim of the symposium is to be able to present new evidence of the new BL/BLI combinations, especially on cefepime-enmetazobactam as one of the latest BL/BLI combination approved in Europe , in order to discuss and resolve the current "AMR puzzle" for the treatment of infections caused by MDR Enterobacterales. The panel of speakers will discuss and provide meaningful education on the appropriate use of the new antibiotics active against MDR bacteria to improve patient outcomes whilst maintaining antimicrobial stewardship."

Infectious Disease

Overall response and microbiological eradication of cefepime/enmetazobactam vs piperacillin/tazobactam in patients with acute pyelonephritis: a post-hoc subgroup analysis from the ALLIUM phase III trial (ESCMID Global 2026) - No abstract available

Clinical • P3 data • Retrospective data • Nephrology

Activity of cefepime/enmetazobactam against highly multidrug-resistant bacterial isolates recovered from war-associated wounds in Ukraine. (PubMed, JAC Antimicrob Resist) - "Cefepime/enmetazobactam improved susceptibility relative to cefepime, most notably in Enterobacterales, but activity was constrained by permeability defects and non-target β-lactamases. Combination therapy with agents that does not get hydrolysed by MBLs and integrated β-lactamase detection with practical permeability indicators may optimize the clinical use of this combination in high-resistance settings."

Journal • Infectious Disease • Pneumonia

Cefepime/Enmetazobactam as a Carbapenem-Sparing Alternative: Activity Against Extended-Spectrum β-Lactamase-Producing Enterobacteria With and Without Carbapenemases in Southern Spain. (PubMed, APMIS) - "This study aims to evaluate the activity of Cefepime/enmetazobactam (FEP/META) in a Regional Hospital in southern Spain, against a collection of ESBL-producing Enterobacteriaceae with or without carbapenemases, comparing it with piperacillin/tazobactam (PIP/TAZ) and meropenem (MER). FEP/META represents a promising therapeutic option for the treatment of infections caused by Gram-negative bacteria resistant to third-generation cephalosporins. It could also be an alternative to OXA-48 carbapenemase-producing Enterobacteriaceae."

Journal • Infectious Disease

Cefepime/enmetazobactam for Gram-negative periprosthetic joint infections? A randomized porcine study on target tissue pharmacokinetics. (PubMed, J Antimicrob Chemother) - "Cefepime/enmetazobactam demonstrated robust tissue distribution, reaching the applied pharmacokinetic/pharmacodynamic targets in all investigated tissue compartments, regardless of the mode of administration. From a pharmacokinetic view, cefepime/enmetazobactam may prove useful in future Gram-negative periprosthetic joint infection settings."

Journal • PK/PD data • Preclinical • Infectious Disease