EC approves Pfizer’s Emblaveo for multidrug-resistant infection treatment
Betsy Goodfellow | April 22, 2024 | News story | Medical Communications | Emblaveo, European Commission, Immunology, Pfizer
Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Emblaveo (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) and complicated urinary tract infections (cUTI), including pyelonephritis.
The drug is also indicated for the treatment of infections from aerobic Gram-negative organisms in adult patients who have limited treatment options.
This approval follows results from the previously reported phase 3 programme, which included the REVISIT and ASSEMBLE trials, assessing the safety, efficacy and tolerability of Emblaveo in treating serious infections due to Gram-negative bacteria. The results demonstrated that the drug is effective and well-tolerated, and no new safety findings were reported compared to aztreonam alone.
This marketing authorisation is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
Marketing authorisation applications for the drug are expected to be submitted in other countries imminently.
Alexandre de Germay, chief international commercial officer and executive vice president at Pfizer, commented: “The European Medicines Agency’s (EMA) 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.”
Betsy Goodfellow
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