Pfizer’s antibiotic combination, Emblaveo (aztreonam-avibactam), has been recommended by the European Medicines Agency’s human medicines committee to treat infections caused by multidrug-resistant bacteria.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that Emblaveo be used 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.
Declared by the World Health Organization (WHO) as one of the top ten threats to global public health, antimicrobial resistance occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases.
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 CHMP’s decision was supported by safety and efficacy data already available for each active substance and positive results of two phase 3 randomised studies, REVISIT and ASSEMBLE, which evaluated Emblaveo in serious bacterial infections due to Gram-negative bacteria.
The European Commission will now review the recommendation, with a final decision expected in the coming months. If approved, Emblaveo would be the first beta-lactam/beta-lactamase inhibitor combination for treating serious bacterial infections caused by multidrug-resistant Gram-negative bacteria, including metallo-beta-lactamase-producing bacteria, approved for use in the EU.
James Rusnak, senior vice president and chief development officer, internal medicine, anti-infectives and hospital at Pfizer, said: “Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients very ill and at high risk of severe complications, including mortality.
“If approved, Emblaveo could offer hope to adult patients with life-threatening Gram-negative bacterial infections that currently have limited treatment options. This recommendation is a positive step for patients with Gram-negative infections resistant to nearly all available antibiotics…”
Emblaveo was jointly developed with AbbVie, which holds rights to the therapy in the US and Canada.