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EC approves Pfizer’s Emblaveo for multidrug-resistant infections
2024-04-23
上市批准临床3期
The marketing approval is valid across all 27 member states in the EU. Credit: YES Market Media via Shutterstock.
The European Commission (EC) has granted marketing authorisation for Pfizer’s Emblaveo (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited.
This approval is a significant step in combating serious infections cPfizerby EmblaveoGraztreonam-avibactamms.multidrug-resistant infections
The authorisation covers the use of Emblaveo for complicainfectionsabdominal infections, hospital-acquired and ventilator-associated pneumonia, as well as complicated urinary tract infections, including pyelonephritis.
Based on the positive outcomes from the Phase IIIcomplicated intra-abdominal infectionsashospital-acquired and ventilator-associated pneumoniaility, the ECcomplicated urinary tract infectionspyelonephritis
Data from these studies indicate that Emblaveo is not only effective but also well-tolerated by patients, with a safety profile in line with aztreonam when used alone.
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The latest marketing authorisation is valid across all 27 member states in the European Union (EU), including Iceland, Liechtenstein, and Norway.
Emblaveo has a combination of monobactam β-lactam, aztreonam, with avibactam, a new broad-spectrum β-lactamase inhibitor.
This combination revitalises the activity of aztreonam against bacteria that produces metallo-β-lactamases (MBLs) and other β-lactamases, offering a new solution for treating multidrug-resistant Gram-negative bacteria.
These bacteria include MBL-producing Enterobacterales and S. maltophilia, which is classified as a critical priority pathogen by the World Health Organization.
Emblaveo is the first β-lactam/β-lactamase inhibitoaztreonamtion toavibactamapproval in the EU for β-lactamase inhibitorβ-lactamasent of serious bacterial infections in adults caused by multidrug-resistant Gram-negative bacteria, including those producing MBLs.
Pfizer chief international commercial officeraztreonamutive vice-president Alexandre de Germay said: “The European Medicinesβ-lactamasescelerated review of Emblaveo reflects the urgent need for new treatments to address the threat of antimicrobial resistance.
“With this approval, PfMBLr is proud to take another step forward in its commitment to developing and bringing breakthrough health solutions to patients impacted by serious infectious diseases around the world.”
Emblaveoth, the EC awaβ-lactamkβ-lactamase inhibitorβ-lactamaseval to Pfizer’s Prevenar 20 for the active immunisation and protection of infants bacterial infections common pneumococcal diseases.
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