FDA approves Pfizer Inc. (PFE.US)/AbbVie (ABBV.US) small molecule therapy

AbbVie (ABBV.US) announced that the U.S. FDA has approved the marketing of Emblaveo (aztreonam and avibactam), a product developed in partnership with Pfizer Inc. (PFE.US). Emblaveo is approved for use in combination with metronidazole to treat patients aged 18 and older with complicated intra-abdominal infections (cIAI), including those caused by multiple drug-resistant gram-negative bacteria. These patients lack alternative treatment options. The press release notes that Emblaveo is the first fixed-dose, intravenous single-ring -lactam/-lactamase inhibitor combination antibiotic approved by the FDA. Emblaveo is a combination antibiotic composed of a single-ring -lactam antibiotic aztreonam and the -lactamase inhibitor avibactam. Previously released data shows that Emblaveo has a cure rate of 76.4% in cIAI patients, compared to a cure rate of 74.0% in patients treated with the active control drug. Public information reveals that Emblaveo was jointly developed by Pfizer Inc. and AbbVie. Pfizer Inc. holds the global rights to commercialize the treatment outside of the U.S. and Canada, while AbbVie holds the rights to Emblaveo in the U.S. and Canada.