European Commission approves novel antibiotic

The European Commission (EC) has granted marketing authorisation for the first EU-approved β-lactam/β-lactamase inhibitor antibiotic combination as a treatment for serious infections in adults caused by multidrug-resistant Gram-negative bacteria. EMBLAVEO ^® (aztreonam-avibactam) is indicated for adults with complicated intra-abdominal infections (cIAI) and hospital-acquired pneumonia (HAP).

This includes ventilator-associated pneumonia (VAP) and complicated urinary tract infections (cUTIs). The combination treatment is also approved for adults with limited treatment options who have infections caused by aerobic Gram-negative bacteria.

“The European Medicines Agency’s accelerated review of EMBLAVEO reflects the urgent need for new treatments to address the threat of antimicrobial resistance [AMR],” shared Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer.

Pfizer stated that EMBLAVEO combines aztreonam, a monobactam β-lactam, with avibactam. The latter is a recent broad-spectrum β-lactamase inhibitor. The combination of aztreonam with avibactam restores aztreonam’s activity against bacteria that co-produce metallo-β-lactamases (MBLs) and other β-lactamases. Overall, it offers a “well-tolerated and effective” treatment option against multidrug-resistant Gram-negative bacteria. 

Approval of EMBLAVEO – another step in addressing antimicrobial resistance

This approval under accelerated assessment is based on results from a Phase III programme consisting of the REVISIT and ASSEMBLE clinical trials.

These studies evaluated the efficacy, safety, and tolerability of EMBLAVEO in treating serious bacterial infections due to Gram-negative bacteria. This includes MBL-producing multidrug-resistant pathogens for which there are limited or no treatment options, Pfizer noted.

The marketing authorisation of EMBLAVEO is valid in all 27 European Union (EU) Member States. This is in addition to Iceland, Liechtenstein, and Norway. MAAs for EMBLAVEO are planned for submission in other countries, according to Pfizer.

Last month, prior to this new authorisation by the European Commission, EMBLAVEO received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) as a treatment against Gram-negative bacteria.

EMBLAVEO was jointly developed with AbbVie. Pfizer added that it holds the global rights to commercialise this antibiotic combination outside of the US and Canada, where the rights for EMBLAVEO are held by AbbVie.