- EMBLAVEO® is the first β-lactam/β-lactamase inhibitor
antibiotic combination approved in the European Union for treating
serious infections in adult patients caused by multidrug-resistant
Gram-negative bacteria, including metallo-β-lactamase-producing
bacteria
- EMBLAVEO® was reviewed under European Medicines Agency
accelerated assessment procedure, used when a pharmaceutical
product is of major interest for public health and therapeutic
innovation
Pfizer Inc. (NYSE: PFE) today announced 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 due to aerobic Gram-negative organisms in adult patients
with limited treatment options.
“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 REVISIT study. “The approval of EMBLAVEO
is welcome news for the infectious disease community and provides
new hope to critically ill patients affected by antimicrobial
resistance.”
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 biggest threats
to global health.1 If AMR 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.1 Multidrug-resistant Gram-negative
bacteria are of particular concern due to the high rates of
morbidity and mortality they cause.2,3 Metallo-β-lactamases (MBLs)
are a type of enzyme produced by certain bacteria that can result
in resistance to antibiotics, and MBL-producing Gram-negative
bacteria are on the rise globally.4 Developing new treatments for
infections caused by Gram-negative bacteria has been prioritized by
the World Health Organization (WHO) as a critical area of focus due
to their increasing spread.1,5
“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.
“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.”
This approval is based on results from the previously reported
Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE
(NCT03580044) studies evaluating the efficacy, safety, and
tolerability of EMBLAVEO in treating serious bacterial infections
due to Gram-negative bacteria, including MBL-producing
multidrug-resistant pathogens for which there are limited or no
treatment options.6,7 Data support that EMBLAVEO is effective and
well-tolerated, with no new safety findings and a similar safety
profile to aztreonam alone.8
The marketing authorization of EMBLAVEO is valid in all 27
European Union (EU) member states, as well as in Iceland,
Liechtenstein, and Norway. Marketing authorization applications for
EMBLAVEO are planned for submission in other countries.
About EMBLAVEO® (aztreonam-avibactam)
EMBLAVEO® 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. It combines
aztreonam, a monobactam β-lactam, with avibactam, a recent
broad-spectrum β-lactamase inhibitor.9,10 MBLs are a class of
β-lactamase enzymes that are not inhibited by current β-lactamase
inhibitors and hydrolyze nearly all β-lactam antibiotics, with an
exception being monobactams such as aztreonam. However, monobactams
are degraded by other β-lactamases that are frequently co-produced
with MBLs, limiting the clinical usefulness of aztreonam
monotherapy.9
The combination of aztreonam with avibactam restores aztreonam’s
activity against bacteria that co-produce MBLs and other
β-lactamases and provides a well-tolerated and effective treatment
option against multidrug-resistant Gram-negative bacteria.9 These
multidrug-resistant Gram-negative bacteria include MBL-producing
Enterobacterales, which have been highlighted as a critical
priority pathogen by the WHO, and S. maltophilia.4,11 EMBLAVEO is
the first β-lactam/β-lactamase inhibitor combination for treating
serious bacterial infections in adult patients caused by
multidrug-resistant Gram-negative bacteria, including MBL-producing
bacteria, approved for use in the EU.
EMBLAVEO was jointly developed with AbbVie. Pfizer holds the
global rights to commercialize this therapy outside of the U.S. and
Canada, where the rights are held by AbbVie. Development of
EMBLAVEO was also supported by public-private partnerships between
Pfizer and the U.S. 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’s Innovative Medicines
Initiative (IMI) – a partnership between the EU and the European
pharmaceutical industry – under a project called COMBACTE-CARE
(Combatting Bacterial Resistance in Europe – Carbapenem
Resistance). The COMBACTE-CARE consortium is a unique
public-private collaboration that unites the knowledge and
capabilities of leading drug-resistant bacterial infection experts
and is supported by the COMBACTE pan-European clinical and
laboratory networks.
About Pfizer: Breakthroughs That Change Patients’
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development, and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world’s premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
175 years, we have worked to make a difference for all who rely on
us. We routinely post information that may be important to
investors on our website at www.Pfizer.com. In addition, to learn
more, please visit us on www.Pfizer.com and follow us on X at
@Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer/.
Category: Prescription Medicines
Disclosure Notice
The information contained in this statement is as of April 22,
2024. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about EMBLAVEO
(aztreonam-avibactam), including its potential benefits, a
marketing authorization granted by the European Commission, and
planned regulatory submissions in other countries, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
uncertainties regarding the commercial success of EMBLAVEO; the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for our clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
the possibility of unfavorable new clinical data and further
analyses of existing clinical data; the risk that clinical trial
data are subject to differing interpretations and assessments by
regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when any drug applications may be filed in any other
jurisdictions for EMBLAVEO; whether and when regulatory authorities
in any such other jurisdictions where applications may be filed or
pending may approve such applications, which will depend on myriad
factors, including making a determination as to whether the
product’s benefits outweigh its known risks and determination of
the product’s efficacy, and whether EMBLAVEO will be commercially
successful; decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of EMBLAVEO; the
impact of COVID-19 on our business, operations and financial
results; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2023 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results,” as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
_________________ 1 World Health Organization. Antimicrobial
resistance. November 2023. Available at:
https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance.
Last accessed April 2024. 2 Review on Antimicrobial Resistance.
Tackling drug-resistant infections globally: final report and
recommendations. May 2016. Available at:
https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf.
Last accessed April 2024. 3 Oliveira J, Reygaert WC. Gram-Negative
Bacteria. [Updated August 8, 2023]. In: StatPearls [Internet].
Treasure Island (FL): StatPearls Publishing. January 2024.
Available at: https://www.ncbi.nlm.nih.gov/books/NBK538213/. Last
accessed April 2024. 4 Boyd SE, Livermore DM, Hooper DC, et al.
Metallo-β-lactamases: Structure, function, epidemiology, treatment
options, and the development pipeline. Antimicrob Agents Chemother.
2020;64(10):e00397-20. 5 World Health Organization. Prioritization
of pathogens to guide discovery, research and development of new
antibiotics for drug-resistant bacterial infections, including
tuberculosis. September 2017. Available at:
https://www.who.int/publications/i/item/WHO-EMP-IAU-2017.12. Last
accessed April 2024. 6 Pfizer. Phase 3 studies of Pfizer’s novel
antibiotic combination offer new treatment hope for patients with
multidrug-resistant infections and limited treatment options. June
2023. Available at:
https://www.pfizer.com/news/press-release/press-release-detail/phase-3-studies-pfizers-novel-antibiotic-combination-offer.
Last accessed April 2024. 7 Carmeli Y. Efficacy and safety of
aztreonam-avibactam for the treatment of serious infections due to
gram-negative bacteria, including metallo-β-lactamase-producing
pathogens: phase 3 REVISIT study. Presented as oral session
(abstract 2893) at IDWeek 2023; 11–15 October, 2023; Boston MA.
2893. 8 Pfizer data on file. ATM-AVI Top-Line Report C3601009. 9
Rossolini GM, Stone G, Kantecki M, et al. In vitro activity of
aztreonam/avibactam against isolates of Enterobacterales collected
globally from ATLAS in 2019. J Glob Antimicrob Resist.
2022;30:214–221. 10 Cornely OA, Cisneros JM, Torre-Cisneros J, et
al. Pharmacokinetics and safety of aztreonam/avibactam for the
treatment of complicated intra-abdominal infections in hospitalized
adults: results from the REJUVENATE study. J Antimicrob Chemother.
2020;75(3):618–627. 11 World Health Organization. WHO publishes
list of bacteria for which new antibiotics are urgently needed.
February 2017. Available at:
https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed.
Last accessed April 2024.
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