European Commission Clears Pfizer’s EMBLAVEO® for Multidrug-Resistant Infections

Pfizer Inc. (NYSE: PFE) has received approval from the European Commission (EC) for EMBLAVEO® (aztreonam-avibactam), expanding treatment options for adult patients facing complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. This medication is also intended for treating infections caused by aerobic Gram-negative organisms in adults with limited treatment choices.

Yehuda Carmeli, Head of the National Institute for Antibiotic Resistance and Infection Control at Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study, remarked, “The approval of EMBLAVEO is welcome news for the infectious disease community and provides new hope to critically ill patients affected by antimicrobial resistance.”

The rise of antimicrobial resistance (AMR) poses a significant threat to global health, with multidrug-resistant Gram-negative bacteria being particularly concerning due to their high rates of morbidity and mortality. Metallo-β-lactamases (MBLs), enzymes produced by certain bacteria, contribute to antibiotic resistance, and their prevalence is increasing worldwide. Consequently, developing new treatments for infections caused by Gram-negative bacteria has become a priority area of focus for organizations like the World Health Organization (WHO).

Alexandre de Germay, Chief International Commercial Officer and Executive Vice President at Pfizer, emphasized the importance of EMBLAVEO’s approval in addressing the urgent need for new treatments to combat antimicrobial resistance.

This approval is based on data from the Phase 3 REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies, demonstrating EMBLAVEO’s efficacy, safety, and tolerability in treating serious bacterial infections caused by Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens.

The marketing authorization for EMBLAVEO encompasses all 27 European Union (EU) member states, as well as Iceland, Liechtenstein, and Norway. Plans for submitting marketing authorization applications in other countries are underway.

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