The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam + avibactam) for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), complicated urinary tract infections (cUTI), and infections caused by aerobic Gram-negative organisms in adults. The drug was reviewed under an accelerated assessment process due to its potential as a new option in the fight against antimicrobial resistance (AMR).
The approval decision is supported by late-stage clinical trial data that demonstrated Emblaveo’s effectiveness and tolerability, with a safety profile comparable to aztreonam alone.
Pfizer now intends to file for review of Emblaveo in additional markets outside of Canada and the US, where development partner AbbVie (NYSE: ABBV) holds the commercialization rights.- Flcube.com
