Pfizer’s Emblaveo (aztreonam-avibactam) has secured marketing authorisation from the European Commission (EC) for the treatment of adult patients with multidrug-resistant infections and who have limited treatment options.
The EC approval covers adults having complicated intra-abdominal infections (cIAI) and hospital-acquired pneumonia (HAP). This includes ventilator-associated pneumonia (VAP) and complicated urinary tract infections (cUTI), including pyelonephritis.
Additionally, the drug is indicated for infections caused by aerobic Gram-negative organisms in adults with restricted treatment options.
Emblaveo underwent review through the European Medicines Agency (EMA) accelerated assessment procedure, which is employed for pharmaceutical products deemed of significant importance for public health and therapeutic advancement.
Pfizer chief international commercial officer and executive vice president Alexandre de Germay said: “The European Medicines Agency’s accelerated review of EMBLAVEO reflects the urgent need for new treatments to address the threat of antimicrobial resistance.
“With this approval, Pfizer is proud to take another step forward in its commitment to developing and bringing breakthrough health solutions to patients impacted by serious infectious diseases around the world.”
The EC`s approval of Emblaveo has been driven by the findings from a Phase 3 programme, which included the REVISIT and ASSEMBLE studies.
These trials assessed its efficacy, safety, and tolerability in addressing severe bacterial infections caused by Gram-negative bacteria, including Metallo-β-lactamase (MBL)-producing multidrug-resistant pathogens, for which treatment options are scarce or absent.
Data affirm that Emblaveo is efficacious and well-tolerated, with no novel safety concerns and a safety profile comparable to aztreonam alone.
Emblaveo, which has been jointly developed by Pfizer and AbbVie, blends aztreonam, a monobactam β-lactam, with avibactam, a recently developed broad-spectrum β-lactamase inhibitor.
According to Pfizer, the combination of aztreonam with avibactam reinstates aztreonam`s effectiveness against bacteria co-producing MBLs and other β-lactamases. This combination offers a well-tolerated and efficacious treatment choice against multidrug-resistant Gram-negative bacteria, said the US-based pharma major.
Pfizer holds the global rights for commercialisation of this therapy except in the US and Canada, where AbbVie holds the rights.
In February 2024, Pfizer obtained marketing authorisation from the EC for Velsipity (etrasimod) for the treatment of a type of ulcerative colitis.
