Whippany, N.J. — Bayer said the U.S. Food and Drug Administration has approved AMBELVIST, a new intravenous macrocyclic gadolinium-based contrast agent for contrast-enhanced magnetic resonance imaging.
AMBELVIST, also known as gadoquatrane, is approved to detect and visualize lesions with abnormal vascularity in the central nervous system and non-CNS body regions in adult and pediatric patients, including term neonates.
Bayer said AMBELVIST is a next-generation macrocyclic gadolinium-based contrast agent with a novel tetrameric structure and high relaxivity, a measure of signal enhancement.
With the approval, AMBELVIST becomes the lowest-dose macrocyclic gadolinium-based contrast agent approved in the United States, according to Bayer. The recommended dose is 0.01 mmol/kg actual body weight, delivering 0.04 mmol gadolinium per kilogram of body weight.
Bayer said that represents 60% less gadolinium compared with macrocyclic gadolinium-based contrast agents with a gadolinium content of 0.1 mmol/kg body weight and 20% less gadolinium compared with gadopiclenol, which has a gadolinium content of 0.05 mmol/kg body weight.
Contrast-enhanced MRI is used by clinicians to detect abnormalities, monitor disease progression and inform treatment decisions. Bayer said some adults and children with chronic diseases or conditions requiring long-term monitoring, including multiple sclerosis, other neurological or spinal conditions and different types of cancer, may need regular imaging.
“I often rely on contrast-enhanced MRI exams to inform clinical decision making,” said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies. “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need.”
The approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of AMBELVIST in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI.
The studies showed increased lesion visualization with combined pre-contrast and post-contrast MRI sets using the reduced gadolinium dose in AMBELVIST compared with pre-contrast MRI images alone.
Bayer said visualization scores and the number of lesions identified by blinded independent readers for AMBELVIST at 0.01 mmol/kg body weight were similar to other tested macrocyclic gadolinium-based contrast agents with a gadolinium content of 0.1 mmol/kg body weight in descriptive analyses.
The safety and effectiveness of AMBELVIST for MRI use in detecting and visualizing lesions with abnormal vascularity in the brain, spine and associated tissues, as well as the head and neck, thorax, abdomen, pelvis and musculoskeletal system, have been established in pediatric patients, including term neonates.
Use in pediatric patients is supported by adult studies and additional pharmacokinetic and safety data from 93 pediatric patients aged 28 days to under 18 years who received one dose of AMBELVIST and underwent MRI of any body region.
AMBELVIST includes a boxed warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis. It is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. Bayer said warnings and precautions also include hypersensitivity reactions, gadolinium retention, acute kidney injury and interference with lesion visualization.
Bayer said it has played a pioneering role in MRI contrast agent development since launching the first gadolinium-based contrast agent in 1988.
“At Bayer, our focus has always been on enhancing patient care, and we are proud to introduce AMBELVIST as our next-generation option for contrast-enhanced MRI,” said Jill Carbone, Vice President and Head of Radiology, North America Product & Pipeline, Bayer. “As a lower-gadolinium-dose GBCA, AMBELVIST supports healthcare providers in adhering to growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients.”
