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Cision Canada
06-05-2025
- Business
- Cision Canada
SILVER ONE ANNOUNCES IN-GROUND MINERAL RESOURCE ESTIMATE PREPARED IN ACCORDANCE WITH NI 43-101 ON ITS CANDELARIA PROJECT, NEVADA
VANCOUVER, BC, May 6, 2025 /CNW/ -- Silver One Resources Inc. (TSXV: SVE) (OTCQX: SLVRF) (FSE: BRK1) ("Silver One" or the "Company") is pleased to announce the completion of a NI 43-101 mineral resource estimate ("MRE") for its Candelaria Project (the "Project"), located in Nevada, USA. The mineral resource estimate, prepared by James A. McCrea, P. Geo, includes the in-ground mineralization and stockpiles adjacent to the historic Mount Diablo and Northern Belle pits (Table 1). The MRE was prepared in accordance with the 2014 Canadian Institute of Mining, Metallurgy and Petroleum ("CIM") Definition Standards and Canadian National Instrument ("NI 43-101"). Highlights: Mount Diablo and Northern Belle pit-constrained resources: - Measured and Indicated (M&I) resource of 22,070,000 tonnes averaging 94 g/t Ag and 0.20 g/t Au, for 66.754 million ounces of silver and 141,400 ounces of gold, or 70.836 million ounces of silver equivalent ("AgEq") (see note ˧ in table 1). - Inferred resource of 2,960,000 tonnes averaging 68 g/t Ag and 0.18 g/t Au, for 6.462 million ounces of silver and 17,000 ounces of gold (7.00 million oz AgEq). Underground Measured and Indicated resource of 1,200,000 tonnes averaging 168 g/t Ag and 0.27 g/t Au, for 6.45 million ounces of silver and 10,200 ounces of gold (7.150 million oz AgEq). Underground Inferred resource of 650,000 tonnes averaging 150 g/t Ag and 0.24 g/t Au, for 3.136 million ounces of silver and 5,100 ounces of gold (3.490 million oz AgEq). C andelaria's project resources (from open-pit, underground, stockpiles and leach pads) now total 108.82 million ounces of silver equivalent in the Measured and Indicated categories, and 29.81 million ounces of silver equivalent Inferred. Greg Crowe, President and CEO commented: "This updated mineral resource is based on results from extensive reverse circulation and core drilling programs and metallurgical studies completed by Silver One. It also includes historic drill hole information from previous operators. We are very pleased with the results. At this phase, the majority of the resource has been upgraded to a Measured and Indicated category. The current resource estimate exceeds the historic resource, which is encouraging as the current resource is pit-constrained and of higher confidence than historic estimates, plus the mineralization remains open in all directions. Additionally, the company's efforts of testing a novel non-cyanide recovery process have yielded excellent results and have demonstrated the capacity to increase silver and gold recoveries, while potentially lowering process costs. The Company plans to resume drilling late in the year to continue expanding the in-ground mineralization, both in the near-surface mineralization and the higher-grade underground targets. Metallurgical testing of the new non-cyanide technology will continue to further examine the optimization of silver and gold recoveries. Silver One is undertaking a PEA study to compare the recoveries and costs of using cyanide versus these new non-cyanide solutions. It is also examining a pilot heap-leach test to investigate field silver and gold recoveries." Silver One previously announced a NI 43-101 mineral resource for mineralization in leach pads on August 18, 2020. The leach pad resources include 22.18 million tonnes for 30.02 million ounces of silver and 52,000 ounces of gold (at a grade of 42.1 g/t Ag and 0.074 g/t Au respectively) in the Indicated category, and 11.45 million tonnes for 15.4 million ounces of silver and 36,700 ounces of gold (at grade of 41.8 g/t Ag and 0.10 g/t Au respectively) in the Inferred category. Indicated and Inferred silver equivalent ounces (AgEq) total 30.8 and 16.1 million ounces respectively (Table 2). Table 1. Candelaria in-ground, underground, and stockpiles mineral resource estimates. Infographic - Totals above include pit Constrained Mineral Resources (Mt. Diablo and Northern Belle) at a US$9.273 NSR cut-off, within a US$27.50/oz Ag optimized pit shell (see footnotes and Resource Estimate Details section below). 1. A Mineral Resource is a concentration or occurrence of solid material of economic interest in or on the Earth's crust in such form, grade or quality and quantity that there are reasonable prospects for eventual economic extraction. An Inferred Mineral Resource is that part of a Mineral Resource for which quantity and grade or quality are estimated on the basis of limited geological evidence and sampling. Geological evidence is sufficient to imply but not verify geological and grade or quality continuity. An Inferred Mineral Resource has a lower level of confidence than that applying to an Indicated Mineral Resource and must not be converted to a Mineral Reserve. It is reasonably expected that the majority of Inferred Mineral Resources could be upgraded to Indicated Mineral Resources with continued exploration. An Indicated Mineral Resource is that part of a Mineral Resource for which quantity, grade or quality, densities, shape, and physical characteristics are estimated with sufficient confidence to allow the application of Modifying Factors in sufficient detail to support mine planning and evaluation of the economic viability of the deposit. Geological evidence is derived from adequately detailed and reliable exploration, sampling and testing and is sufficient to assume geological and grade or quality continuity between points of observation. An Indicated Mineral Resource has a lower level of confidence than that applying to a Measured Mineral Resource and may only be converted to a Probable Mineral Reserve. 2. Mineral resources, which are not mineral reserves, do not have demonstrated economic viability. The estimate of mineral resources has no known issues and does not appear materially affected by any known environmental, permitting, legal, title, socio-political, marketing, or other relevant issues. There is no guarantee that Silver One will be successful in obtaining any or all of the requisite consents, permits or approvals, regulatory or otherwise for the project or that the project will be placed into production. 3. The mineral resources in this study were estimated using the Canadian Institute of Mining, Metallurgy and Petroleum ('CIM'), CIM Standards on Mineral Resources and Reserves, Definitions and Guidelines prepared by the Standing Committee on Reserve Definitions and adopted by the CIM Council on May 10, 2014. 4. This Mineral Resource Estimate for the near-surface material is based on material within an optimized open pit shell that results from a US$27.50/oz silver price revenue factor. Tonnes and grade reported at $27.50/oz Ag and U$2,106/oz Au. 5. The Mineral Resource Estimate for underground material was calculated using a 90 g/t Ag(T) cut-off below the $27.50 Pit and using a 70% mining recovery. 6. Total Ag (AgT) and Au (AuT) mean total silver and gold assays (FA/Gravity) reported by the lab. It also means Calculated silver and gold values for historic samples collected by previous operators that were assayed for cyanide soluble silver or gold only, but not assayed for total gold and silver. Average total silver and gold for Mt. Diablo, Northern Belle and Underground resources in this table are derived from silver and gold assays in a database that consists of up to 80% of cyanide soluble silver and gold assays only. Approximately 20% of the assays in the database have both FA and or gravity total silver and gold values. The latter constitutes the basis for the generation of the Calculated silver and gold values using regression formulas developed by qualified Silver One professionals. Table 2. Candelaria Leach Pad mineral resources. As reported on August 18, 2020 company's news release. Infographic - Candelaria's project resources now total 108.822 million ounces of silver equivalent ("AgEq") in the Measured and Indicated categories, and 29.808 million ounces of silver equivalent including in-ground, leach pad and stockpiles material. Higher grade material such as the underground resource, contains a significant amount of zinc. However, owing to the scarcity of base metal assays in most of the database, base metals are not included in this resource estimate at this time. This report brings to current, upgrades and expands the historic resource of the Mount Diablo, Northern Belle and Stockpiles reported by SSR in a Technical Report filed on SEDAR in 2002, and complements the resource estimate of the leach pads reported by the company in 2020 (See the Company's news release of August 18, 2020). Metal prices used for this resource estimate are US $27.50 per ounce of silver and US $2,106 per ounce of gold. These prices are used for the exploitation scenarios related to reasonable prospects for eventual economic extraction. The 3-year trailing average metal prices are US $2,146 per ounce of gold and US $25.11 per ounce of silver. Spot prices for April 30, 2025 were US 3,328 per ounce of gold and US $33.19 per ounce of silver. To fulfill the requirement of reasonable prospects for economic extraction ("RPEEE"), a conceptual crushing and leaching scenario using the Merrill-Crowe process was developed based on the results of the High-Pressure Grinding Rolls ("HPGR") and column cyanide leach tests. These metallurgical tests were completed by McClelland Laboratories Inc. and Kappes Cassiday & Associates ("KCA") in Reno, Nevada (see Company's news release May 21, 2019). The scenarios evaluated were developed based on an operational throughput of 10,000 per day (tpd). The base case was using a silver recovery of 56%, 66% and 55% for oxide, mixed and sulfide material respectively, and gold recoveries of 51%, 10% and 0% for oxide, mixed and sulfide, respectively. These metal recoveries are estimated field recoveries which are discounted by a factor of 9% from laboratory column test recoveries, as normally done in practice by KCA for feasibility study purposes. The mining and heap-leach processing assumptions for RPEEE are shown in Table 3. Table 3. Mining and Heap Leach Processing assumptions for RPEEE. The above assumptions use an open-pit mining internal cut-off NSR value of US$9.27/tonne (equivalent to a cut-off grade between 14.81 g/t AgEq to $17.78 g/t AgEq depending on the rock and mineralization type). Cut-off for underground mining is 90 g/t Ag. Resource Estimate Details The constraining pit for RPEEE was designed using 6m and 3m block size and the Lerch-Grossman "LG" algorithm. The optimal pit resulted from a US$27.50 g/t Ag and US$2,106 g/t Au price revenue factor and was used as a pit shell for the near-surface resource estimate. Tonnage and grade reported was tabulated at US$27.50/oz Ag and US$2,106/oz Au. Specific gravities were calculated from 78 laboratory measurements of all types of mineralized materials. Averages are 2.52 g/cm 3 for oxide and mixed mineralization, 2.66 g/cm 3 for sulfides, and 2.37 g/cm 3 for all other rock materials. Historical mine workings at Northern Belle were digitized in mine grid from various maps, vertical and longitudinal sections and solid wireframes were built and converted to UTM coordinates. Volume of workings were calculated and deducted from the respective block affected. Measured, Indicated and Inferred Mineral Resources were determined from respective classification search ranges for Mt Diablo: Classification search ranges for Northern Belle: Underground resources were tabulated using a 90 g/t Ag(T) cut-off below the $27.50 Pit and using a 70% mining recovery. The Mineral Resource Estimate is based on a drill hole database containing 938 surface RC, percussion and diamond drill holes totaling 143,389 metres of drilling and 76,796 assays. Historic drilling (90% of the drillholes with only cyanide soluble assays) was converted from mine grid to UTM by surveying mine grid points in UTM and doing a grid conversion. Verification of the interpolation of the resource model included visual inspections of the block grades versus composite values and geologic model, block model swash plots for soluble silver, and a 'one out' cross-validation. A Technical report in support of the MRE, dated effective April 30, 2025 titled "Technical Report on the Candelaria Property, Mineral and Esmeralda Counties, Nevada, USA" was prepared by James A. McCrea, P. Geo., in accordance with the requirements of NI 43-101, and will be filed on SEDAR+ within 45 days of this press release. Candelaria Project Background Candelaria was historically the highest-grade silver producer in the state of Nevada, averaging over 1,200 g/T AgEq (40 oz/t AgEq) from high-grade vein mining between the mid-1800s and the mid-1900s. Open pit mining operations mined silver and base metals from stockwork and manto-style mineralized bodies with accessory gold values hosted in rocks of the Candelaria and Pickhandle Gulch formations. The majority of the mineralization is associated with the Lower Candelaria shear and Pickhandle thrusts. Open-pit mining was undertaken in the 1970s through 1998 by several companies, including Nerco, Inc. and Kinross. Kinross closed the open pit and leach operation in 1998 due to low silver prices. Leaching of the historic pads was not completed leaving a substantial amount of silver unprocessed. It is estimated that the property has produced over 68 million ounces of silver. Historical information was obtained from "Geology of the Candelaria Mining District, Mineral County, Nevada, 1959, Nevada Bureau of Mines, Bulletin 56", and the SSR Mining Inc. technical report titled "Candelaria Project Technical Report" dated May 24, 2001 (filed on SEDAR June 20, 2002), prepared by Pincock Allen & Holt. Qualified Persons The mineral resource estimate was prepared by James A. McCrea, P. Geo, an independent Qualified Person as defined by National Instrument 43-101 who has reviewed and approved the content of the news release relating to the mineral resource estimate. The technical content of this news release, not related to the mineral resource estimate, has been reviewed and approved by Robert M. Cann, P. Geo, a Qualified Person as defined by National Instrument 43-101 and an independent consultant to the Company. About Silver One Silver One is focused on the exploration and development of quality silver projects. The Company holds 100% interest in its flagship project, the past-producing Candelaria Mine located in Nevada. Potential reprocessing of silver from the historic leach pads at Candelaria provides an opportunity for possible near-term production. Additional opportunities lie in previously identified high-grade silver intercepts down-dip and potentially increasing the substantive silver mineralization along-strike from the two past-producing open pits. The Company owns 636 lode claims and five patented claims on its Cherokee project located in Lincoln County, Nevada, host to multiple silver-copper-gold vein systems, traced to date for over 11 km along-strike. Silver One also owns a 100% interest in the Silver Phoenix Project. The Silver Phoenix Project is a very high-grade native silver prospect that lies within the "Arizona Silver Belt," immediately adjacent to the prolific copper producing area of Globe, Arizona. For more information, please contact: Silver One Resources Inc. Gary Lindsey - VP, Investor Relations Phone: 604-974‐5274 Mobile: (720) 273-6224 Email: [email protected] Forward-Looking Statements Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management's current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. Silver One cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond Silver One's control. Such factors include, among other things: risks and uncertainties relating to Silver One's limited operating history, ability to obtain sufficient financing to carry out its exploration and development objectives on the Candelaria Project, obtaining the necessary permits to carry out its activities and the need to comply with environmental and governmental regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, Silver One undertakes no obligation to publicly update or revise forward-looking information.
Yahoo
21-02-2025
- Politics
- Yahoo
American Legion national Commender coming to La Crescent to speak on veteran suicide and other pressing veteran matters
LA CRESCENT, Min. (WLAX/WEUX) – American Legion National Commander James A. LaCoursiere Jr. of Connecticut is coming to La Crescent and will speak on issues of importance to Minnesota veterans. LaCoursiere is strongly committed to raising awareness for The American Legion's 'Be the One' efforts to prevent veteran suicide. 'It is the most significant issue facing veterans,' he told the national convention after being elected in August. 'It is the most significant issue of our time. It's also an issue that galvanizes all of us. I know that we are all touched by someone who has taken their own life.' He will visit La Crescent Area Event Center at 595 Veterans Pkwy. for a social hour, dinner and presentation starting at 5:30 pm on Tuesday, March 25th. LaCoursiere will talk with veterans, community leaders and local residents. The visit is hosted by the veterans of La Crescent American Legion Post 595. The American Legion also is focused on stopping veteran claim sharks, passage of the Major Richard Star Act (which eliminates concurrent receipt on military retirement pensions), implementation of the PACT Act, parity for the federal definition of a veteran, full accountability of POW/MIAs, ending veteran homelessness, paying the Coast Guard during federal shutdowns, and passage of an amendment to protect the U.S. flag from desecration. Post 595 plans to celebrate The American Legion's birthday as well. Any local residents wishing to attend can contact Ricard Acevedo. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Associated Press
07-02-2025
- Health
- Associated Press
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 NORTH CHICAGO, Ill., Feb. 7, 2025 /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 (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 Reactions Hypersensitivity 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 Disorders Cases 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 Reactions Elevations 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 Diarrhea Clostridioides 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 Bacteria Prescribing 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 REACTIONS The 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 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 AbbVie AbbVie'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 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 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: Last accessed January 2025. 3 The U.S. Food and Drug Administration. Antimicrobial Resistance. Available at: 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]. . 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]. .
