Pfizer Inc. has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia, and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. Antimicrobial resistance ?

when bacteria, viruses, fungi, and parasites change and find ways to resist the effects of antimicrobial drugs ? is recognized as one of the biggest threats to global health. If AMR continues to rise unchecked, minor infections could become life-threatening, and many routine medical procedures such as caesarean sections and hip replacements could become too risky to perform.1 Multidrug-resistant Gram-negative bacteria are of particular concern due to the high rates of morbidity and mortality they cause.

Metallo-ß-lactamases (MBLs) are a type of enzyme produced by certain bacteria that can result in resistance to antibiotics, and MBL-producing Gram-negative bacteria are on the rise globally.4 Developing new treatments for infections caused by Gram-negative bacteria has been prioritized by the World Health Organization as a critical area of focus due to their increasing spread. This approval is based on results from the previously reported Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and tolerability of EMBLAVEO in treating serious bacterial infections due to Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens for which there are limited or no treatment options. Data support that EMBLAVEO is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone.

The marketing authorization of EMBLAVEO is valid in all 27 European Union member states, as well as in Iceland, Liechtenstein, and Norway. Marketing authorization applications for EMBLAVEO are planned for submission in other countries.