HQ Team
April 22, 2024: The European Commission has granted Pfizer Inc., marketing authorisation for a drug to treat adult patients with intra-abdominal infections, hospital-acquired pneumonia and complex urinary tract infections.
The company’s branded Emblavec or aztreonam-avibactam is also meant to treat infections due to aerobic gram-negative organisms in adult patients with limited treatment options, and ventilator-associated pneumonia, according to a company statement.
Antimicrobial resistance — when bacteria, viruses, fungi, and parasites change and find ways to resist the effects of antimicrobial drugs — is recognised as one of the biggest threats to global health. Gram-negative bacteria are highly resistant to antibiotics.
These microorganisms have significant clinical importance in hospitals because they often require patients to be in the intensive care unit, and patients are at high risk of morbidity and mortality, according to the National Institutes of Health.
Metallo-β-lactamase
The EU approval was based on results from earlier phase 3 clinical trials evaluating the efficacy, safety, and tolerability of the medicine in treating serious bacterial infections due to gram-negative bacteria.
It included multi-drug resistant metallo-β-lactamase producing bacteria for which there are limited or no treatment options. “Data support that Emblaveo is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone.”
Metallo-β-lactamases are a type of enzyme produced by certain bacteria that can result in resistance to antibiotics, and the MBL-producing gram-negative bacteria are on the rise globally, according to Pfizer’s statement.
The drug was reviewed under the European Medicines Agency accelerated assessment procedure, used when a pharmaceutical product is of major interest for public health and therapeutic innovation.
The marketing authorization is valid in all 27 European Union member states, as well as in Iceland, Liechtenstein, and Norway. Marketing authorization applications for the drug are planned for submission in other countries.
`Treatment options daunting’
“For healthcare teams treating patients with serious gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the clinical trials.
“The approval of Emblaveo is welcome news for the infectious disease community and provides new hope to critically ill patients affected by antimicrobial resistance.”
If antimicrobial resistance continues to rise unchecked, minor infections could become life-threatening, and many routine medical procedures such as caesarean sections and hip replacements could become too risky to perform.
Multidrug-resistant gram-negative bacteria are of particular concern due to the high rates of morbidity and mortality they cause.
Developing new treatments for infections caused by gram-negative bacteria has been prioritised by the World Health Organization as a critical area of focus due to their increasing spread.
Joint development with AbbVie
“The European Medicines Agency’s accelerated review of Emblaveo reflects the urgent need for new treatments to address the threat of antimicrobial resistance,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer.
Pfizer’s drug was jointly developed with AbbVie. Pfizer holds the global rights to commercialize this therapy outside of the US and Canada, where the rights are held by AbbVie.
The drug development was backed by public-private partnerships between Pfizer and the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.
It got support from the EU’s Innovative Medicines Initiative — a partnership between the EU and the European pharmaceutical industry.
