2024-04-23 09:33:00
Pfizer, EC approves EMBLAVEO for the treatment of patients with infections caused by multidrug-resistant bacteria and with limited therapeutic options
Pfizer announced today that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections caused by aerobic Gram-negative organisms in adult patients with limited treatment options.
“For medical teams treating patients with serious Gram-negative infections, the prospect of running out of effective treatment options is a real threat“, he has declared Yehuda Carmelihead of the National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and investigator of the study REVISIT. “The approval of EMBLAVEO is good news for the infectious disease community and represents new hope for seriously ill patients affected by antimicrobial resistance“.
The antimicrobial resistance (AMR) – when bacteria, viruses, fungi and parasites change and find ways to resist the effects of antimicrobial drugs – is recognized as one of the major threats to global health. If AMR continues to grow unchecked, even minor infections could become life-threatening, and many routine medical procedures, such as cesarean 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. The metal-β-lactamasi (MBL) are a class of enzymes produced by some bacteria that can cause antibiotic resistance, and Gram-negative bacteria that produce MBL are increasing globally. The development of new treatments for infections caused by Gram-negative bacteria has been considered a priority byWorld Health Organization (WHO) as a critical area due to their increasing diffusion.
“The European Medicines Agency’s fast-track review of EMBLAVEO reflects the urgent need for new treatments to address the threat of antimicrobial resistance“, he has declared Alexandre de GermayChief International Commercial Officer, Executive Vice President di Pfizer. “With this approval, Pfizer is proud to take another step forward in its commitment to develop and bring innovative treatment options to patients affected by serious infectious diseases around the world“.
The approval of aztreonam-avibactam includes the positive results of the program Phase 3 studies previously communicated, including studies REVISIT (NCT03329092) e ASSEMBLE (NCT03580044), who evaluated the efficacy, safety and tolerability of the drug in the treatment of serious bacterial infections due to Gram-negative bacteria, including multidrug-resistant metallo-β-lactamase (MBL)-producing pathogens for which the options therapeutics are limited or absent. The data confirm that aztreonam-avibactam is effective and well tolerated, with no new safety findings and with a safety profile similar to that of aztreonam alone.
The marketing authorization for EMBLAVEO is valid in all 27 member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. Marketing authorization applications for EMBLAVEO are expected to be submitted in other countries.
About EMBLAVEO® (aztreonam-avibactam)
Aztreonam-avibactam is indicated for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), complicated urinary tract infections (cUTI), including pyelonephritis, and infections due to aerobic Gram-negative organisms with limited treatment options. The drug combines aztreonam, a monobactam β-lactam, with avibactam, a broad-spectrum β-lactamase inhibitor.
The metallo-β-lactamase (MBL) are a class of β-lactam enzymes that are not inhibited by current β-lactamase inhibitors and hydrolyze almost all β-lactam antibiotics, with the exception of monobactams such as aztreonam. However, monobactams are degraded by other β-lactamases that are often co-produced with MBLs, limiting the clinical utility of aztreonam monotherapy. The combination of aztreonam with avibactam restores the activity of aztreonam against bacteria that coproduce MBL and other β-lactamases and represents aeffective therapeutic option and well tolerated against multi-resistant Gram-negative bacteria.
These multidrug-resistant Gram-negative bacteria include MBL-producing Enterobacterales, which has been highlighted as a priority critical pathogen by WHO, and Stenotrophomonas maltophilia. And the first β-lactam/inhibitor combination of β-lactamases for the treatment of serious bacterial infections caused by multidrug-resistant Gram-negative bacteria, including MBL-producing bacteria, approved for use in the EU. The drug was developed jointly with AbbVie. Pfizer holds the global rights to market this drug outside the United States and Canada, where the rights are held by AbbVie.
Its development was also supported by public-private partnership between Pfizer and US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under OTA number HHSO100201500029C, and through the EU Innovative Medicines Initiative (IMI) – a partnership between the EU and the European pharmaceutical industry, under a project called COMBACTE-CARE (Combating Bacterial Resistance in Europe – Carbapenem Resistance). The COMBACTE-CARE consortium is a first-of-its-kind public-private collaboration, combining the knowledge and skills of leading experts in drug-resistant bacterial infections and supported by the pan-European COMBACTE clinical and laboratory networks.
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