Pfizer announced today that the European Medicines Agency (EMA) has granted marketing authorization for Emblaveo (aztreonam-avibactam) for treating a host of multidrug-resistant bacterial infections.
Under the EMA approval, Emblaveo is indicated for the treatment of adults who have complicated intra-abdominal infections, hospital-acquired pneumonia (including ventilator-associated pneumonia), and complicated urinary tract infections (including pyelonephritis), as well as infections caused by aerobic gram-negative organisms in patients who have limited treatment options.
Jointly developed by Pfizer and Abbvie, Emblaveo combines a beta-lactam antibiotic (aztreonam) with a beta-lactamase inhibitor (avibactam). The combination aims to restore aztreonam's activity against gram-negative bacteria that carry two defense mechanisms—metallo-beta-lactamase (MBL) enzymes and other beta-lactamase enzymes—that confer resistance to nearly all currently available antibiotics. While aztreonam can evade degradation by MBLs on its own, the addition of avibactam helps restore its activity against other beta-lactamases.
'New hope' for critically ill patients with resistant infections
The approval is based on the results from two phase 3 trials that evaluated the safety and efficacy of Emblaveo.
"For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat," Yehuda Carmeli, head of the National Institute for Antibiotic Resistance and Infection Control at Tel Aviv Medical Center and an investigator in the phase 3 REVISIT study, said in a Pfizer press release. "The approval of Emblaveo is welcome news for the infectious disease community and provides new hope to critically ill patients affected by antimicrobial resistance."
The marketing authorization is valid in all 27 European Union countries and in Iceland, Liechtenstein, and Norway.
The approval of Emblaveo is welcome news for the infectious disease community and provides new hope to critically ill patients affected by antimicrobial resistance.