The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of marketing authorisation for Pfizer’s EMBLAVEO®, a fixed-dose combination of two active substances - aztreonam and avibactam - for adult patients with infections due to exposure to antibiotic-resistant bacteria. The treatment was reviewed under the accelerated assessment procedure because it is considered to be of major public health interest.
If the European Commission grants marketing authorisation for the treatment, EMBLAVEO® would be the first beta-lactam-beta lactamase inhibitor combination therapy intended to treat serious Gram-negative bacterial infections (including MBL Enterobacterales) in adult patients approved for use in the EU.
Specifically, EMBLAVEO® is intended to treat complicated intra-abdominal infections, hospital-acquired pneumonia including ventilator-associated pneumonia, and complicated urinary tract infections, including pyelonephritis. If approved, it will also tackle infections caused by aerobic Gram-negative organisms in adult patients with limited treatment options. Amongst these organisms are the metallo beta-lactamase producing Enterobacterales, which have been highlighted as critical priority pathogens by the WHO, and Stenotrophomonas maltophilia, which cause hard-to-treat lung infections. These severe infections can be life-threatening, and EMBLAVEO® could offer new hope to adult patients.
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.
According to the project partners, the collaboration between academia, industry and the clinical trial sites has been crucial to the success of the COMBACTE-CARE studies, leading to robust patient recruitment and knowledge sharing, as well as demonstrating the value of having a high-quality clinical and laboratory network in Europe.
Next step: the European Commission grants central marketing authorisations in the EU and is set to review the recommendation and make a final decision in the coming months. If granted, the centralised marketing authorisation of EMBLAVEO® would be valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway.
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 media statement.
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
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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.
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