The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in partnership with Pfizer. AbbVie acquired its share of the asset as part of its $63 billion buyout of Allergan.
Emblaveo, a new combination antibiotic developed in a partnership between AbbVie and Pfizer, received FDA approval to address difficult-to-treat intra-abdominal bacterial infections, AbbVie announced on Friday.
Embalveo’s development partnership was originally between Pfizer and Allergan Inc., the latter of which was acquired by AbbVie in June 2019 for a whopping $63 billion. Under the terms of the partnership, AbbVie holds Emblaveo’s rights in the U.S. and Canada, while Pfizer has the rights for the drug in the rest of the world.
Antimicrobial resistance (AMR) is a leading global public health threat, according to the World Health Organization (WHO), with nearly 5 million associated deaths per year—and that number is set to double by 2050 if more treatment options are not able to address the problem. Despite this, investment in the development of new antimicrobials has been falling, with some smaller antibiotic-focused companies filing for bankruptcy while many larger companies have exited the space due to issues in achieving profitability with these treatments.
This is a “classic example of a market failure, with little to no incentive to invest in AMR versus other promising therapeutics,” John Stanford, executive director of Incubate, a coalition of life science venture capital firms, previously told BioSpace.
Emblaveo is a combination of aztreonam, a traditional β-lactam similar to penicillin, and avibactam, an inhibitor of bacterial anti-microbial resistance proteins. It’s approved for use in combination with another antibiotic and antiprotozoal called metronidazole. Emblaveo is indicated for patients who have limited or no other options, with multi-drug resistant intra-abdominal infections caused by Gram-negative bacteria such as E. coli, Klebsiella pneumoniae and Enterobacter.
“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,” infectious disease specialist James A. McKinnell said in a statement from AbbVie.
AbbVie is expecting Emblaveo to hit the U.S. market sometime in the third quarter of 2025. The European Commission approved Emblaveo in April 2024.
In data from the Phase III REVISIT trial, run by Pfizer and announced in October 2024, Emblaveo achieved a cure rate of 76.4%, beating the 74.0% cure rate of meropenem, a current standard antibiotic treatment intra-abdominal Gram-negative infections.
Emblaveo was developed through the FDA’s Qualified Infectious Disease Product pathway, which incentivizes drug companies to create new antibiotics with accelerated approval tracks and a five-year regulatory exclusivity extension.
