EC approves Pfizer’s Emblaveo for multidrug-resistant infections

2024-04-23

上市批准临床3期

来源: Pharmaceutical Technology

The marketing approval is valid across all 27 member states in the EU. Credit: YES Market Media via Shutterstock.

The European Commission (EC) has granted marketing authorisation for Pfizer’s Emblaveo (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited.

This approval is a significant step in combating serious infections caused by aerobic Gram-negative organisms.

The authorisation covers the use of Emblaveo for complicated intra-abdominal infections, hospital-acquired and ventilator-associated pneumonia, as well as complicated urinary tract infections, including pyelonephritis.

Based on the positive outcomes from the Phase III REVISIT and ASSEMBLE clinical trials assessing the treatment’s efficacy, safety, and tolerability, the EC adopted the latest decision.

Data from these studies indicate that Emblaveo is not only effective but also well-tolerated by patients, with a safety profile in line with aztreonam when used alone.

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The latest marketing authorisation is valid across all 27 member states in the European Union (EU), including Iceland, Liechtenstein, and Norway.

Further submissions seeking approval for the treatment are planned for other countries.

Emblaveo has a combination of monobactam β-lactam, aztreonam, with avibactam, a new broad-spectrum β-lactamase inhibitor β-lactamase inhibitor.

This combination revitalises the activity of aztreonam against bacteria that produces metallo-β-lactamases (MBLs) and other β-lactamases, offering a new solution for treating multidrug-resistant Gram-negative bacteria.

These bacteria include MBL-producing Enterobacterales and S. maltophilia, which is classified as a critical priority pathogen by the World Health Organization.

Emblaveo is the first β-lactam/β-lactamase inhibitor β-lactamase inhibitor combination to receive approval in the EU for the treatment of serious bacterial infections in adults caused by multidrug-resistant Gram-negative bacteria, including those producing MBLs.

Pfizer chief international commercial officer and executive vice-president Alexandre de Germay said: “The European Medicines Agency’s accelerated review of Emblaveo reflects the urgent need for new treatments to address the threat of antimicrobial resistance.

“With this approval, Pfizer is proud to take another step forward in its commitment to developing and bringing breakthrough health solutions to patients impacted by serious infectious diseases around the world.”

Last month, the EC awarded marketing approval to Pfizer’s Prevenar 20 for the active immunisation and protection of infants and children against common pneumococcal diseases.

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