AbbVie's Emblaveo approved by US FDA for abdominal infection care

(Alliance News) - AbbVie Inc on Friday said the US Food & Drugs Administration has approved Emblaveo for the treatment of adults with complicated intra-abdominal infections.

The North Chicago, Illinois-based pharmaceuticals firm said Emblaveo is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for treatment of cIAI.

Abbvie said Emblaveo becomes the first monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the US FDA to treat complicated intra-abdominal infections, including those caused by gram-negative bacteria.

James McKinnell, infectious disease specialist, Torrance Memorial Medical Center in Torrance, California said. "The approval of Emblaveo provides physicians a much-needed therapeutic option to help address some of the most difficult antimicrobial-resistant pathogens and provides doctors an opportunity to treat patients with these challenging infections."

The approval was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of cIAI. It was also supported by clinical trial results from the Phase 3 Revisit study, which evaluated the efficacy, safety, and tolerability of Emblaveo for the treatment of serious infections due to gram-negative bacteria, including metallo-β-lactamases-producing multidrug-resistant pathogens, for which there are limited or no treatment options.

Shares in AbbVie were 0.7% lower at USD191.60 each in New York on Friday.

By Jeremy Cutler, Alliance News reporter

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