Pfizer’s antibiotic scores EU approval for Gram-negative infections
Phase 3Drug ApprovalQualified Infectious Disease ProductClinical Result
After receiving a positive vote last month from a European Commission committee, Pfizer’s antibiotic Emblaveo (aztreonam-avibactam) earned full approval from the EU regulator on Monday.
The antibiotic combines aztreonam, a monobactam β-lactam, with avibactam, a broad-spectrum β-lactamase inhibitorβ-lactamase inhibitor, to treat infections caused by multidrug-resistant Gram-negative bacteria, including those that produce metallo-β-lactamase (MBL), an enzyme associated with antibiotic resistance. According to the World Health Organization, the development of antibiotics to treat Gram-negative bacteria-caused infections is a global priority.
Specifically, Emblaveo was granted marketing authorisation to treat adults with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis, as well as infections due to aerobic Gram-negative organisms with limited treatment options.
The approval is based on data from the Phase III REVISIT and ASSEMBLE studies, which showed Emblaveo was well-tolerated and effective at treating infections due to Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens.
“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,” said Yehuda Carmeli, an investigator in the REVISIT study.
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