The European Commission has approved marketing authorisation for Pfizer’s EMBLAVEO®, a fixed-dose combination of two active substances - aztreonam and avibactam - for adult patients with infections due to antibiotic-resistant bacteria. This rapid approval comes following a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), published on 24 March 2024. The treatment was reviewed under the accelerated assessment procedure because it is considered to be of major public health interest.
Gram-negative bacteria that are resistant to many currently available antibiotics cause severe infections and are a serious public health problem since patients have limited or sometimes no treatment options. Up to 35,000 deaths in the EU every year are estimated to be caused by these multi-drug resistant bacteria.
EMBLAVEO® will be the first beta-lactam-beta lactamase inhibitor combination therapy intended to treat serious Gram-negative bacterial infections (including MBL-producing Enterobacterales and Stenotrophomonas maltophilia) in adult patients approved for use in the EU.
Specifically, EMBLAVEO® is indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) where treatment options are limited.
Two of the EMBLAVEO® clinical studies were conducted with the support of the Innovative Medicines Initiative project COMBACTE-CARE – the first was a Phase II study (REJUVENATE) which investigated its potential as a treatment for hospitalised patients with complicated intra-abdominal infections. The second was a Phase III study (REVISIT) which compared the aztreonam-avibactam treatment with meropenem and colistin – a commonly used treatment – to treat complicated intra-abdominal infections, hospital-acquired pneumonia and ventilator-associated pneumonia. The REVISIT study was also supported by the Biomedical Advanced Research and Development Authority (BARDA). Data from the studies showed that the treatment is effective and well-tolerated.
“This is fantastic news coming from the EU co-funded project COMBACTE-CARE under the Innovative Medicines Initiative public-private partnership. It provides a new tool to fight antibiotic resistant bacteria, an area where any new breakthrough treatment makes a real difference on public health,” says Marc Lemaȋtre, Director-General of the European Commission’s directorate general for research and innovation.
“Slowing the spread of antimicrobial resistance requires a collaborative approach, as no one organisation can solve the AMR crisis,” said Juliet McQuillan, EMBLAVEO® Medicine Team Lead, Pfizer. “The collaboration with COMBACTE-CARE and our other partners has been critical in the development and approval of EMBLAVEO®, which brings new hope to patients affected by multidrug-resistant infections.”
Next step: The centralised marketing authorisation of EMBLAVEO® will become valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway.
More information on the European Commission’s decision to grant marketing authorisation in the EU for EMBLAVEO® can be found here.
More information on EMA’s recommendation on the marketing authorisation in the EU for EMBLAVEO® can be found here.
More information about EMBLAVEO® can be found in Pfizer's press release.
Notes to editors
Pfizer holds the global rights to commercialise this investigative therapy outside of the U.S. and Canada, where the rights are held by AbbVie.
The COMBACTE-CARE project is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry. It is also part of the IMI New Drugs for Bad Bugs programme. More information: https://www.ihi.europa.eu/projects-results/project-factsheets/combacte-care
Press contact
Catherine Brett – External Relations Manager
Tel: +32 2 541 8214 | E-mail: catherine.brett@ihi.europa.eu
About IHI
The Innovative Health Initiative (IHI) aims to translate health research and innovation into real benefits for patients and society,and ensure that Europe remains at the cutting edge of interdisciplinary, sustainable, patient-centric health research. Health research and care increasingly involve diverse sectors. By supporting projects that bring these sectors together, IHI will pave the way for a more integrated approach to health care, covering prevention, diagnosis, treatment, and disease management.
IHI is a partnership between the European Union and European industry associations representing the pharmaceutical, medical technology, biotechnology, digital health and vaccine industries, namely COCIR, EFPIA, EuropaBio, MedTech Europe and Vaccines Europe. IHI’s total budget is EUR 2.4 billion. Half of this comes from Horizon Europe, the EU’s research and innovation programme. The IHI industry partners have committed EUR 1 billion to IHI, and a further EUR 200 million can be committed by other organisations that decide to become Contributing Partners.
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