EMA recommends Marketing Authorization for ATM-AVI
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of marketing authorization for Pfizer’s EMBLAVEO® (aztreonam-avibactam, ATM-AVI) in the European Union (EU) 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. If approved, EMBLAVEO® will also be indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.
The treatment was reviewed under the accelerated assessment procedure because it is considered to be of major public health interest.
ATM-AVI in COMBACTE-CARE
ATM-AVI is a beta-lactam/beta lactamase inhibitor combination intended to treat serious Gram-negative bacterial infections in patients with limited or no treatment options. Two of the ATM-AVI clinical studies were conducted with the support of the Innovative Medicines Initiative project COMBACTE-CARE – the phase II and phase III studies, REJUVENATE and REVISIT respectively.
The phase II trial REJUVENATE reported the pharmacokinetics and safety of ATM-AVI in hospitalized patients with complicated intra-abdominal infections and confirmed the dose regimen for the phase III program. REVISIT was a pivotal global phase III trial which evaluated the efficacy, safety, and tolerability of EMBLAVEO® in treating serious bacterial infections due to Gram-negative bacteria. Data from the studies supported that the treatment is effective and well-tolerated.
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.
Pfizer, as sponsor, and COMBACTE-CARE via REVISIT, conducted this program in co-development with AbbVie* and was co-funded by the U.S. Biomedical Advanced Research and Development Authority (BARDA). The COMBACTE-CARE consortium was co-funded by the Innovative Medicines Initiative (now Innovative Health Initiative) as part of the New Drugs for Bad Bugs program.
In June 2023, Pfizer shared positive results from the Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies showing that ATM-AVI is effective and well- tolerated in treating infections caused by Gram-negative bacteria, with a similar safety profile to aztreonam alone. If approved, ATM-AVI could be an important treatment option for patients with life-threatening Gram-negative bacterial infections that are resistant to almost all currently available antibiotics. Read more at Pfizer’s media statement and IHI’s press release.
The study was funded by the Innovative Medicines Initiative Joint Undertaking (https://www.imi.europa.eu/) under Grant Agreement No. 115620 (COMBACTE-CARE), resources of which are composed of financial contributions from the European Union’s Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ in kind contribution. Development of EMBLAVEO was also supported by a public–private partnership 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.
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