The European Medicines Agency (EMA) has recommended marketing authorisation to the European Commission (EC) for an antibiotic which can treat multidrug-resistant infections.
Emblaveo is indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria including aerobic Gram-negative, where treatment options are limited.
Antimicrobial resistance, particularly in Gram-negative bacteria, is one of the biggest threats to global health. The EMA evaluated the medicine under its accelerated assessment programme which reduced the timeline to approval from 210 to 150 days.
The agency’s recommendation is based on the safety and efficacy data available for each active substance, in addition to the results of two phase III studies.
Emblaveo consists of two antibiotics, aztreonam and avibactam. Aztreonam is already authorised for use in the EU on its own, and avibactam in combination with another antibiotic (ceftazidime).
“Emblaveo could offer hope to adult patients with life-threatening Gram-negative bacterial infections that currently have limited treatment options. This recommendation is [good for] for patients with Gram-negative infections [being] resistant to nearly all available antibiotics,” said James Rusnack of Pfizer which developed the antibiotic.
The opinion will be sent to the EC for the adoption of a decision on an EU-wide marketing authorisation.
Further reading
New antibiotic to fight infections caused by multidrug-resistant bacteria: https://www.ema.europa.eu/en/news/new-antibiotic-fight-infections-caused-multidrug-resistant-bacteria
