CHMP positive for Emblaveo (aztreonam + avibactam) for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections due to aerobic Gram-negative organisms.-Pfizer.

The applicant for this medicinal product is Pfizer Europe MA EEIG.

Emblaveo is a fixed dose combination of two active substances (ATC code: J01DF51 aztreonam and beta-lactamase inhibitor), aztreonam and avibactam, and will be available as a powder for concentrate for solution for infusion. Each vial will contain 1.5 g aztreonam and avibactam sodium equivalent to 0.5 g avibactam. Aztreonam is a known monocyclic beta-lactam antibacterial agent (monobactam) that inhibits bacterial cell wall synthesis by targeting penicillin-binding proteins (PBPs). Avibactam is a known beta-lactamase inhibitor that prevents certain classes of beta-lactamases (class A, class C and some class D) from hydrolysing aztreonam.

Studies show that Emblaveo is expected to be effective at treating infections for which aztreonam is already used, as well as infections due to aerobic Gram-negative organisms. Microbiology data indicate that aztreonam in combination with avibactam may also have an important utility in infections caused by metallo-?-lactamase-producing Enterobacterales and the combination could therefore address an unmet medical need. The most common side effects of Emblaveo are anaemia, serum transaminase elevation and diarrhoea.