Pfizer announced last week that its novel investigational combination antibiotic for multidrug-resistant bacterial infections has moved a step closer to regulatory approval in Europe.
In a press release, the company said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the granting of marketing authorization for Emblaveo (aztreonam-avibactam) for treating adults with complicated intra-abdominal infections, hospital-acquired pneumonia (including ventilator-associated pneumonia), complicated urinary tract infections (including pyelonephritis), and infections caused by aerobic gram-negative organisms with limited treatment options.
An option for nearly untreatable infections
Jointly developed by Pfizer and Abbvie, Emblaveo combines an old beta-lactam antibiotic (aztreonam) with a newer 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.
"Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients very ill and at high risk of severe complications, including mortality," said James Rusnak, MD, PhD, Pfizer's senior vice president and chief development officer for internal medicine, anti-infectives and hospital. "If approved, Emblaveo could offer hope to adult patients with life-threatening Gram-negative bacterial infections that currently have limited treatment options."
The European Commission will review the CHMP recommendation and is expected to decide whether to grant central marketing authorizations in the European Union in the coming months.
If approved, Emblaveo could offer hope to adult patients with life-threatening Gram-negative bacterial infections that currently have limited treatment options.