U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options

EMBLAVEOTM is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the U.S. FDA to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria Gram-negative bacterial infections represent a significant public health threat due to their ability to develop resistance to antimicrobial therapies Antimicrobial resistance (AMR) could lead to over 39 million deaths worldwide by 2050, and new treatments are urgently needed1 , /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO™ (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. Gram-negative bacterial infections are among the most challenging for healthcare professionals to control due to high antimicrobial resistance (AMR).2 When AMR develops, medicines intended to treat these infections become ineffective, increasing the risk of morbidity and mortality.2 "The continued evolution of antimicrobial resistance among Gram-negative bacteria has left some patients with little to no treatment options, resulting in extended hospital stays, additional morbidity and death," said James A. McKinnell, M.D., infectious disease specialist, Milefchik-Rand Medical Group, Torrance Memorial Medical Center in Torrance, California. "The approval of EMBLAVEO provides physicians a much-needed therapeutic option to help address some of the most difficult antimicrobial-resistant pathogens and provides doctors an opportunity to treat patients with these challenging infections." AMR is considered an urgent global public health threat and could lead to over 39 million deaths worldwide by 2050.1 An estimated 1.14 million deaths globally were attributed to bacterial AMR in 2021 alone.1 If AMR remains unaddressed, minor infections and routine surgical procedures could become life-threatening or fatal.2 The FDA has prioritized the research and development of new medicines to treat AMR and help prevent the spread of infection.3 "As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health," said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance." EMBLAVEO is a medication that combines two components: aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor that protects aztreonam from serine β-lactamase hydrolysis and restores its activity against bacteria that co-produce Metallo-β-lactamases (MBLs) and serine β-lactamases.4 MBLs are a type of enzyme produced by certain bacteria that can become resistant to antibiotics and are on the rise globally.5 The approval of EMBLAVEO was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of cIAI.6 It was also supported by clinical trial results from the Phase 3 REVISIT study, which evaluated the efficacy, safety, and tolerability of EMBLAVEO for the treatment of serious infections due to Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens, for which there are limited or no treatment options.7 In 2019, the FDA granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for EMBLAVEO.8 The QIDP Designation provides certain incentives for the development of new antibiotics, including priority review and eligibility for the FDA's Fast Track Designation, and a five-year regulatory exclusivity extension.8 The Fast Track Designation is designed to facilitate the development of and accelerate the review of drugs to treat serious conditions that do not have sufficient treatment options.8 EMBLAVEO will be available for commercial use in the U.S. in Q3 2025. About the Phase 3 REVISIT Study7 The Phase 3 REVISIT clinical trial is a randomized, active-controlled, central assessor-blinded, multicenter trial evaluating EMBLAVEO ± metronidazole versus the combination of meropenem ± colistin in patients with cIAI or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (not an approved indication for EMBLAVEO). The study enrolled 422 patients across 81 locations globally. The primary endpoint was clinical cure at the test-of-cure visit in the intent-to-treat (ITT) population. Secondary endpoints included 28-day mortality in the ITT population, and safety in patients in the ITT population who received the study drug. The REVISIT trial included 312 hospitalized patients with cIAI that were randomized 2:1 to receive treatment with EMBLAVEO with metronidazole or meropenem ± colistin for five to 14 days of therapy. The trial was not designed with any formal hypotheses for inferential testing against the active comparator. More information on the study can be found on www.clinicaltrials.gov (NCT03329092) and in The Lancet Infectious Disease. About EMBLAVEO™ EMBLAVEO™ is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. It combines aztreonam, a monobactam β-lactam, with avibactam, a broad-spectrum β-lactamase inhibitor.4 Metallo-β-lactamases (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.4,5 However, monobactams are degraded by other β-lactamases that are frequently co-produced with MBLs, limiting the clinical usefulness of aztreonam monotherapy.4,5 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.4,7 These multidrug-resistant Gram-negative bacteria include carbapenem-resistant Enterobacterales (CRE) and S. maltophilia.4,5 CRE, including those that produce MBLs, have been highlighted as an urgent threat by the U.S. Centers for Disease Control and Prevention.9 In April 2024, the European Commission granted marketing authorization for EMBLAVEO® for the treatment of adult patients with cIAI, hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.10 It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.10 The marketing authorization for EMBLAVEO was approved in Great Britain in June 2024, and other global submissions are ongoing. EMBLAVEO was jointly developed with Pfizer. AbbVie holds the rights to commercialize the therapy in the U.S. and Canada, with Pfizer responsible for commercialization in all other areas. Development of EMBLAVEO was also supported by public-private partnerships with 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 Combatting Bacterial Resistance in Europe – Carbapenem Resistance (COMBACTE-CARE), grant agreement No. 115620. 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. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE Complicated Intra-abdominal Infections EMBLAVEO, in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative treatment options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. CONTRAINDICATIONS EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam). WARNINGS AND PRECAUTIONS Hypersensitivity ReactionsHypersensitivity reactions were noted in patients treated with EMBLAVEO, including rash, flushing, and bronchospasm. Prior to treatment, it should be established if the patient has a history of hypersensitivity reactions to components of EMBLAVEO (aztreonam and avibactam). In case of hypersensitivity reactions, immediately discontinue EMBLAVEO and initiate appropriate medications and/or supportive care. Serious Skin DisordersCases of toxic epidermal necrolysis have been reported in association with aztreonam (a component of EMBLAVEO) in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis. Discontinue EMBLAVEO if a serious skin reaction occurs. Hepatic Adverse ReactionsElevations in hepatic transaminases have been observed during treatment with EMBLAVEO. Monitoring of liver-related laboratory tests is recommended while on treatment, particularly in patients with baseline liver comorbidities or on concomitant hepatotoxic medications. If transaminase elevations are noted, consider discontinuing EMBLAVEO, if clinically indicated, and monitor the patient for resolution of any pertinent clinical and laboratory findings. Clostridioides Difficile-Associated DiarrheaClostridioides difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs, including EMBLAVEO, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial drugs alters the normal flora of the colon and may permit overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial drugs. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated. Development of Drug-Resistant BacteriaPrescribing EMBLAVEO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONSThe most common adverse reactions occurring at an incidence of greater than 5% were hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for Full Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on X (formerly Twitter), Facebook, Instagram, YouTube, and LinkedIn. Forward-Looking Statements  Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.  Contact(s): U.S. Media: Alyssa Rege[email protected] Investors: Liz Shea[email protected] References 1 Naghavi, Mohsen, et al. "Global burden of bacterial antimicrobial resistance 1990–2021: A systematic analysis with forecasts to 2050." The Lancet, vol. 404, no. 10459, 16 Sept. 2024, pp. 1199–1226. 2 World Health Organization. Antimicrobial resistance. November 2023. Available at: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance. Last accessed January 2025. 3 The U.S. Food and Drug Administration. Antimicrobial Resistance. Available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance. Last accessed January 2025. 4 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. 5 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. 6 AZACTAM®, Package Insert. Bristol Myers Squibb, 2018. 7 Carmeli Y, Cisneros-Herreros JM, Paul M, et al. Aztreonam–avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial. Lancet Infect Dis 2024:S1473-3099(24)00499-7. 8 AbbVie. Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections [Press Release]. https://news.abbvie.com/2019-11-11-Allergan-Receives-FDA-Qualified-Infectious-Disease-Product-QIDP-Designation-And-Fast-Track-Designation-For-ATM-AVI-Aztreonam-And-Avibactam-For-Antibiotic-Resistant-Gram-Negative-Infections. 9 Centers for Disease Control and Prevention. Carbapenem-resistant Enterobacterales (CRE): An urgent public health threat. July 2021. Available at: https://www.cdc.gov/antimicrobial-resistance/about/index.html. Last accessed January 2025. 10 Pfizer Inc. European Commission Approves Pfizer's EMBLAVEO® for Patients with Multidrug-Resistant Infections and Limited Treatment Options [Press Release]. https://www.pfizer.com/news/press-release/press-release-detail/european-commission-approves-pfizers-emblaveor-patients#:~:text=It%20combines%20aztreonam%2C%20a%20monobactam,9. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options

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