The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for aztreonam-avibactam (Emblaveo), indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by aerobic Gram-negative bacteria where treatment options are limited.

Emblaveo is a fixed-dose combination of two active substances, aztreonam and avibactam. Aztreonam is already authorised for use in the EU on its own and avibactam is authorised for use in combination with ceftazidime. 

Avibactam works by blocking the action of many of the bacterial enzymes called beta-lactamases. These enzymes enable bacteria to break down beta-lactam antibiotics, such as aztreonam, making them resistant to the antibiotic’s action. By blocking these enzymes, avibactam restores the activity of aztreonam against aztreonam-resistant bacteria.

Emblaveo is given by intravenous infusion. It was evaluated under the EMA’s accelerated assessment mechanism because it is considered to be of major public health interest.