FDA approves Emblaveo for treating severe intra-abdominal infections

USA – The FDA has approved Emblaveo, a new intravenous antibiotic developed by Pfizer and AbbVie, designed to combat complicated intra-abdominal infections (cIAI).

This fixed-dose combination of aztreonam and avibactam will be used alongside metronidazole to treat cIAI caused by specific Gram-negative bacteria in patients aged 18 and older who have limited or no alternative treatment options.

Emblaveo consists of two key components: aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor.

Avibactam is crucial because it protects aztreonam from breakdown by serine β-lactamase enzymes, enabling it to target bacteria that produce both Metallo-β-lactamases and serine β-lactamases.

This makes it particularly effective against resistant strains of bacteria, including Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.

The drug’s approval was supported by findings from the Phase III REVISIT trial, which evaluated its safety and efficacy.

The study involved 312 hospitalized patients with cIAI who were treated with Emblaveo and metronidazole or a comparator regimen of meropenem with or without colistin.

Results showed a comparable cure rate, with Emblaveo achieving a success rate of 76.4% versus 74% in the comparator group. This highlighted its effectiveness as a viable treatment option.

In addition to data from the trial, existing safety and efficacy information about aztreonam also played a role in the FDA’s decision.

AbbVie, which holds rights to Emblaveo in the US and Canada, plans to launch the drug in the third quarter of this year, while Pfizer will handle commercialization in other global markets.

Notably, Emblaveo has already received approval from the European Commission earlier this year, not only for treating cIAI but also for hospital-acquired pneumonia, including ventilator-associated pneumonia, and complicated urinary tract infections.

“Emblaveo represents an important step forward for patients dealing with resistant infections where few options exist,” said experts involved in the drug’s development.