WHIPPANY, N.J.--(BUSINESS WIRE)--The Journal of the American College of Cardiology published results of the Phase III GadaCAD 1 and GadaCAD 2 clinical trials for Gadavist® (gadobutrol) in their September 29, 2020 issue. The publication includes data that supported the FDA approval of Gadavist to assess myocardial perfusion (stress, rest) and late gadolinium enhancement (LGE) in adult patients with known or suspected coronary artery disease (CAD).
The Journal of the American College of Cardiology publication of this data further validates Gadavist-enhanced cardiac MR as a non-invasive method available to evaluate patients with known or suspected coronary artery disease,” said Daniel S. Berman, MD, FACC, Chief of Cardiac Imaging and Nuclear Cardiology at the Cedars-Sinai Heart Institute and the S. Mark Taper Foundation Imaging Center. "Since its FDA approval last year, physicians have a tool that they can use to assess these patients and help guide their patient management decisions.”
A disease affecting approximately 16.5 million Americans, CAD develops when the major blood vessels that supply the heart with blood, oxygen and nutrients (coronary arteries) become damaged or diseased.1,2 Cholesterol-containing deposits (plaque) in the arteries and inflammation are usually the cause of CAD. Eventually, the decreased blood flow may cause chest pain (angina), shortness of breath, or other coronary artery disease signs and symptoms. A complete blockage can cause a heart attack.2
The two multinational, multicenter, non-randomized Phase III studies looked at approximately 1,000 adults with suspected or known CAD based on signs and symptoms. Nearly 800 of those patients were evaluated for efficacy. As the design and results for GadaCAD1 and GadaCAD2 were very similar, results were summarized at the individual reader level (three readers per trial), the clinical trial level, and as a meta-analysis combining both clinical trials. To provide an overall summary result, a fixed-effect meta-analysis method was used to summarize data for the six total readers. This methodology was chosen as the two trials had similar sensitivity and specificity, nearly identical methodology, the same study drug and dose, the same standard of reference methods and core laboratories, and populations with similar prevalence of CAD. The publication, including individual reader results and the meta analysis can be viewed here: https://www.onlinejacc.org/content/76/13/1536.
The findings supported the FDA’s approval of Gadavist-enhanced cardiac MR in July 2019, making it the first and only contrast agent approved for use in cardiac MR – an important diagnostic tool for adult patients with known or suspected CAD. The Society for Cardiovascular Magnetic Resonance recognizes cardiac MR as a non-invasive tool that provides relevant and actionable information to healthcare professionals.3
“The publication of this data in such a prominent journal underscores Gadavist’s ability to help provide important diagnostic information to help guide patient management decisions,” said Olaf Weber, Head of Radiology Research and Development, Bayer. “Not only does this research add to the existing body of scientific knowledge for CAD, but also underscores our dedication to research to advance disease diagnosis.”
Please see Gadavist Important Safety Information, including Box Warning below, and for more information, please visit www.radiologysolutions.bayer.com/products/mr/contrast/gadavist/
About Gadavist
Gadavist® (gadobutrol) injection was first approved in the U.S. in 2011 for intravenous use in magnetic resonance (MR) imaging in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadavist was further approved in the U.S. in 2014 for MR of the breast in adult patients to assess the presence and extent of malignant breast disease and for pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. In 2016, it was approved in the U.S. for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.
Gadavist, also known as Gadovist® and Gadovist® 1.0 in other regions, is the U.S. brand name of the aqueous 1.0M solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for MRI with a macrocyclic structure. The safety profile of Gadavist has been established in clinical trials involving 7,713 patients (including 184 pediatric patients ages 0-17). The safety and effectiveness of Gadavist have not been established in preterm neonates for any indication or in pediatric patients of any age for use with MR to assess the presence and extent of malignant breast disease, or for use in cardiac MR to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in patients with known or suspected coronary artery disease (CAD). Please see Important Safety Information, including Boxed Warning below.
INDICATIONS and IMPORTANT SAFETY INFORMATION
INDICATIONS
Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):
- To detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
- To assess the presence and extent of malignant breast disease in adult patients.
- To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
Gadavist® is indicated for use in magnetic resonance angiography (MRA):
- To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.
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.
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Contraindication and Important Information about Hypersensitivity Reactions:
Gadavist® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist® administration. Before Gadavist® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist®.
Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.
Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of GBCAs. Do not exceed the recommended dose in these patients.
Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation.
Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.
Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist® MRA for detecting arterial segments with significant stenosis (>50% renal, >70% supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA study alone should not be used to rule out significant stenosis.
Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.7%), nausea (1.2%) and dizziness (0.5%).
Please see Full Prescribing Information for Gadavist® (Vials and Syringes).
Please see Full Prescribing Information for Gadavist® (Pharmacy Bulk Package).
Please see Full Prescribing Information for Gadavist® (Imaging Bulk Pack).
https://www.radiologysolutions.bayer.com/products/contrast-agents/gadavist-injection-pi
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1 Cleveland Clinic. Coronary Artery Disease. https://my.clevelandclinic.org/health/diseases/16898-coronary-artery-disease. Updated May 14, 2019. Accessed May 23, 2019.
2 Mayo Clinic. Coronary artery disease. https://www.mayoclinic.org/diseases-conditions/coronary-artery-disease/symptoms-causes/syc-20350613. Accessed May 23, 2019.
3 Society for Cardiovascular Magnetic Resonance: Why CMR. (n.d.). https://scmr.org/page/WhyCMR. Accessed May 23, 2019.
October 2020 PP-GADA-US-0387-1
