European Commission Approves Pfizer’s EMBLAVEO for Patients with Multidrug-Resistant Infections and Limited Treatment Options

Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) 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 (VAP), 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.

“For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study. “The approval of EMBLAVEO is welcome news for the infectious disease community and provides new hope to critically ill patients affected by antimicrobial resistance.”

Antimicrobial resistance (AMR) – 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.¹ 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.^2,3 Metallo-β-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 (WHO) as a critical area of focus due to their increasing spread.^1,5

“The European Medicines Agency’s accelerated review of EMBLAVEO reflects the urgent need for new treatments to address the threat of antimicrobial resistance,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With this approval, Pfizer 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.”