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Pfizer’s antibiotic combination receives EC approval to treat multidrug-resistant infections

Pfizer’s antibiotic combination receives EC approval to treat multidrug-resistant infections

Pfizer’s antibiotic combination, Emblaveo (aztreonam-avibactam), has been approved by the European Commission (EC) to treat patients with multidrug-resistant infections. Antimicrobial resistance has been declared by WHO as one of the top ten threats to global health. The regulator has authorised Emblaveo for use in adults with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by aerobic Gram-negative bacteria where treatment options are limited.

The decision makes Emblaveo the first beta-lactam/beta-lactamase inhibitor antibiotic combination approved in the EU for treating serious bacterial infections caused by multidrug-resistant Gram-negative bacteria, including metallo-beta-lactamase-producing bacteria.

Declared by the World Health Organization (WHO) as one of the top ten threats to global health, antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi and parasites change and find ways to resist the effects of antimicrobial drugs. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases.

Multidrug-resistant Gram-negative bacteria are of particular concern due to the high rates of morbidity and mortality they cause.

Emblaveo is a fixed-dose combination of two active substances: aztreonam and avibactam. Aztreonam attaches to proteins on the surface of bacteria to prevent them from building their cell walls, which kills them. Meanwhile, avibactam blocks the action of enzymes that enable bacteria to break down and become resistant to aztreonam and other beta-lactam antibiotics.

The EC’s decision on the combination follows a recent recommendation from the European Medicines Agency’s (EMA) human medicines committee and was supported by previously-reported results from a late-stage programme comprising REVISIT and ASSEMBLE, which evaluated Emblaveo in serious bacterial infections due to Gram-negative bacteria.

REVISIT investigator Yehuda Carmeli, of Tel Aviv Medical Center, said: “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. “The approval of Emblaveo is welcome news for the infectious disease community and provides new hope to critically ill patients affected by AMR.” Alexandre de Germay, chief international commercial officer, executive vice president, Pfizer, said: “The EMA’s accelerated review of Emblaveo reflects the urgent need for new treatments to address the threat of AMR.”

Emblaveo was jointly developed with AbbVie, which holds rights to the therapy in the US and Canada.

April 24, 2024

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