AbbVie scores FDA nod for Pfizer-partnered antibiotic Emblaveo
By Kevin Dunleavy Feb 10, 2025 8:09am
Ten months after Pfizer scored approval in Europe for Emblaveo (aztreonam and avibactam) to treat complicated intra-abdominal infections (cIAIs), AbbVie has done the same in the U.S., winning an FDA nod for Emblaveo for the same type of infections.
In a collaboration between two of the industry’s largest drugmakers, AbbVie and Pfizer jointly developed Emblaveo, with the Illinois company holding its rights in the U.S. and Canada while its partner controls rights for the rest of the world.
The FDA approval covers Emblaveo to be used in combination with the antibiotic metronidazole for patients with cIAIs who have limited or no other options.
Emblaveo can be used to treat Gram-negative infections including E. coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex and Serratia marcescens.
These infections can be difficult to treat as the bacteria causing them can become resistant to common antibiotics. Antimicrobial resistance (AMR) is a serious public health risk, causing an estimated 1.14 million deaths globally in 2021 with the potential to cause 39 million deaths by 2050, according to a study published last year in The Lancet.
“The continued evolution of antimicrobial resistance among Gram-negative bacteria has left some patients with little to no treatment options, resulting in extended hospital stays, additional morbidity and death,” James McKinnell, M.D., infectious disease specialist at the Torrance Memorial Medical Center in California, said in a release.
According to the World Health Organization, AMR “puts many of the gains of modern medicine at risk,” making infections harder to treat and other medical procedures—such as surgery, caesarean sections and cancer chemotherapy—much riskier.
Emblaveo is a combination of aztreonam, a monobactam antibiotic, and avibactam, a beta-lactamase inhibitor that can restore the ability of aztreonam to fight the types of bacteria than can become resistant to most antibiotics.
Emblaveo received qualified infectious disease product and fast track designations from the FDA in 2019. Grants from the Biomedical Advanced Research and Development Authority and the EU’s Innovative Medicines Initiative helped fund it development.
AbbVie expects Emblaveo to become available in the third quarter of this year. The company did not reveal its price.
“As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health,” Roopal Thakkar, M.D., AbbVie’s chief scientific officer, said in the release.
Comments