PR Newswire
PRINCETON, N.J., Nov. 22, 2022
PRINCETON, N.J., Nov. 22, 2022 /PRNewswire/ -- Guerbet LLC, the US affiliate of Guerbet, a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, will present data on Elucirem™ (gadopiclenol) injection, Dotarem® (gadoterate meglumine) injection and AI solutions at the 2022 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting.
"It's very exciting to be back at RSNA, to give the radiology community a first-hand opportunity to experience the clarity of MRI images offered by our new MRI product, Elucirem™," said David Hale, Chief Executive Officer of the Guerbet Group. "We look forward to sharing insights about gadopiclenol, a novel, highly stable macrocyclic gadolinium-based contrast agent offering the highest relaxivity in its class for magnetic resonance imaging.2"
Elucirem® is indicated for use with MRI in adults and pediatric patients aged two years and older to detect and visualize lesions in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system).1
For Elucirem®, Guerbet received Priority Review by the US Food and Drug Administration (FDA) on the basis of the unmet medical needs, as there are currently no U.S. approved and marketed MRI contrast agents indicated for musculoskeletal lesion visualization and no macrocyclic GBCAs approved broadly to visualize lesions located throughout the body.3 Guerbet received US FDA's marketing approval for Elucirem on September 21, 2022.
Elucirem® (gadopiclenol) injection will be available in glass vials, glass pharmacy bulk packages and in plastic pre-filled syringes, which can help to streamline workflow in the imaging suite. All gadopiclenol is manufactured by Guerbet Group Company.
ELUCIREM (gadopiclenol) injection and DOTAREM (gadoterate meglumine) injection Important Safety Information
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) See full prescribing information for complete boxed warning Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.
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Opportunities to Learn More at RSNA 2022
RSNA Innovation Theater -- @ 1:00 – 1:15 p.m. CST, Monday November 28, 2022: Aashim Bhatia, MD, MS, Assistant Professor in Radiology and Pediatric Neuroradiologist at the Children's Hospital of Philadelphia will be presenting Guerbet's Latest Innovation: Illuminating the Possibilities with a Novel New Drug https://eppro02.ativ.me/web/planner.?id=RSNA22&table=agenda&tid=S1138
Oral and Poster Presentations:
Title | Author(s) | Date/Time | Session Number |
Reduced Body Gd Exposure over 5 months after a single Human Equivalent Dose of Gadopiclenol as compared to Gadobutrol in Healthy Rats | M. Rasschaert, C. Eoulourmyl Strzeminska, C. Walton, M. Lefebvre, N. Decout, C. Factor, P. Robert | Dec. 1 – 12:15 p.m. – 12:45 p.m. | RSA-SPNPM |
Efficacy and safety of gadopiclenol for central nervous system (CNS) magnetic resonance imaging (MRI): The Picture Trial | Leo Wolansky | Nov. 30 1:30 p.m. – 2:30 p.m. | W6 – SSNR13 |
Efficacy and safety of gadopiclenol for central nervous system (CNS) magnetic resonance imaging (MTI): The Picture Trial | Christiane Kuhl | Nov. 27 2:30 p.m. – 3:30 p.m. | S5 – SSMSO1 |
Use of real life safety data from international pharmacovigilance databases to assess the importance of symptoms associated with gadolinium exposure | Imran Shahid, Eric Lancelot | Dec. 1 12:15 p.m. – 12:45 p.m. | R5A - SPNR |
Super-dose: a deep learning method to increase the sensitivity of MRI in neuro-oncology via virtual dose amplification | Alexandre Bone Dr. Samy Ammari | Thu. Nov. 30 12:45 p.m. – 1:15 p.m. | W5B - SPNR |
Multi-head deep learning model for the detection of prostate cancer lesions in bi-parametric MRI | Kourosh Jafari-Khouzani, Maria Victoria Sainz de Cea, Wen Wei, Aly Mohamed, Noelle Debs, Alexandre Routier, Onofrio Caralano, Marwan Sati, Amin Katouzian | Tue, Nov. 29 12:45pm - 1:15pm Scientific Poster Sessions | Learning Center – IN DPS T5B-SPIN-4 |
Comparison of three methods for lesion detection and classification on bi-parametric MRI | Maria V. Sainz de Cea, Kourosh Jafari-Khouzani, Wen Wei, Aly A. Mohamed, Noelie Debs, Alexandre Routier, Marc-Michel Rohe, Russell Klenk, Onofrio Catalano, Amin Katouzian | Tue, Nov. 29 9:00am - 9:30am Scientific Poster Sessions | T2-SPGU-3 |
Rigorous Comparison of a New Fully Automated Deep Learning Algorithm for Detection of Focal Liver Lesions in Abdominal Contrast CT with Radiologists | Dufort, G. Palma, P. L. Esquinas Fernandez, Y. Wang, O. Bonakdar Sakhi, F. C. Commandeur, A. Sitek, F. Louvet-De Verchere, K. Siewert, K. Tipton | Tue, Nov. 29 1:30pm - 2:30pm | T6-SSGI10-4 |
Guerbet's RSNA Education & Research Award Recipient 2022
As part of its continued partnership with the Radiological Society of North America (RSNA), Guerbet is proud to announce that the RSNA Research & Education (R&E) Foundation Board of Trustees has awarded the Guerbet Research Scholar Grant to Vivek Yedavalli, MD, MS from Johns Hopkins School of Medicine. Dr. Yedavalli was awarded $75,000 per year for two years to support his study, Deep Learning Models Using Baseline Comprehensive CT Stroke Collateral Imaging in Cerebral Angiographic Collateral, Post Procedural Hemorrhagic Transformation, and Clinical Outcomes Predictions for Increasing Thrombectomy Eligibility. The RSNA R&E Foundation invests in the future of radiology by developing investigators and supporting lifelong innovative research and education.
Digital Solutions Featured at Booth #1711
Guerbet will also feature a collection of digital and AI software-based products that help to close the loop with the smart connectivity between monitoring and reporting:
About Guerbet |
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At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 8%-10% of our revenue to research and development in five centers in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €732 million in revenue in 2021. For more information, please visit www.guerbet.com. |
About Gadopiclenol
Gadopiclenol, which was initially invented by Guerbet, with the subsequent contribution of Bracco's intellectual property, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of gadopiclenol have been evaluated in MRI of the Central Nervous System (brain, spine and associated tissues) and Body (head and neck, thorax, abdomen, pelvis and musculoskeletal system. The details of Phase III clinical trials are available on www.ClinicalTrials.gov:
Forward-looking statements
This press release may contain statements of a forward-looking nature, based on assumptions and predictions made by the management of the Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to marked differences between the future results, financial situation, development and performances of the company, and the estimates made here. These factors include those mentioned in the public reports of Guerbet, available on its website www.guerbet.com. The company assumes no responsibility whatsoever in relation to the updating of these forward-looking statements, or how they correspond to future events or developments.
ELUCIREMTM (gadopiclenol) injection Important Safety Information
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) See full prescribing information for complete boxed warning Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.
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Indications and Usage
ELUCIREMTM (gadopiclenol) injection is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
Contraindications
History of hypersensitivity reactions to ELUCIREM.
Warnings and Precautions
Adverse Reactions:
In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling. Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg BW ELUCIREM included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase.
Use in Specific Populations
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 see the full Prescribing Information, including the Medication Guide and Boxed Warning, for additional important safety information.
DOTAREM® (GADOTERATE MEGLUMINE) INJECTION IMPORTANT SAFETY INFORMATION
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. • The risk for NSF appears highest among patients with: o Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or o Acute kidney injury. • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. • For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration. Werbung Mehr Nachrichten zur Global Blood Therapeutics Aktie kostenlos abonnieren
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