Bayer announced that the US Food and Drug Administration (FDA) approved AMBELVIST (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-Based Contrast Agent (mGBCA) indicated for contrast-enhanced Magnetic Resonance Imaging (MRI) to detect and visualise lesions with abnormal vascularity in the Central Nervous System (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates.

AMBELVIST is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement).

With this approval, AMBELVIST becomes the lowest-dose mGBCA in the US.

AMBELVIST has a recommended dose of 0.01 mmol/kg actual body weight (which delivers 0.04 mmol Gd/kg body weight), representing 60 percent less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20 percent less Gd compared to gadopiclenol with a Gd content of 0.05 mmol Gd/kg body weight.

Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body. This type of study can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions. For some adults and children with chronic diseases or conditions that require close, long-term monitoring—such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer—regular, serial images may be required.

Dr. Christopher Hancock, Director of Neuroradiology, HALO Diagnostics Desert Cities, and an investigator for the QUANTI clinical studies, said, “I often rely on contrast-enhanced MRI exams to inform clinical decision making. 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.”