The European Commission has approved EMBLAVEO® (aztreonam-avibactam) as a treatment for severe infections caused by Gram-negative bacteria. This includes complicated intra-abdominal infections, hospital-acquired pneumonia, and urinary tract infections, including pyelonephritis. It may also be used to treat infections in patients with limited treatment options due to antimicrobial resistance.
Antimicrobial resistance (AMR), where microbes develop resistance to antibiotics, poses a significant global threat. Gram-negative bacteria, particularly those that produce metallo-β-lactamases (MBLs), are a major concern due to their high mortality rates.
The European Medicines Agency’s accelerated review of EMBLAVEO® highlights the urgent need for new treatments to combat AMR. Pfizer’s commitment to developing innovative solutions for infectious diseases is reflected in this approval.
Clinical studies have demonstrated the efficacy and safety of EMBLAVEO®. It has a similar safety profile to aztreonam alone, with no new adverse effects observed. The marketing authorization is valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway.
Pfizer plans to file marketing authorization applications for EMBLAVEO® in other countries worldwide. Its approval provides hope for patients facing the challenges of AMR and offers healthcare professionals a new weapon in the fight against serious bacterial infections.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
