Bayer has received U.S. Food and Drug Administration (FDA) approval for its gadoquatrane MRI contrast agent Ambelvist, indicated for detecting and visualizing 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 macrocyclic gadolinium-based contrast agent (mGBCA) for contrast-enhanced MRI, having a recommended dose of 0.01 mmol/kg body weight, delivering 0.04 mmol of gadolinium per kilogram. This represents 60% less gadolinium than mGBCAs dosed at 0.1 mmol Gd/kg and 20% less than gadopiclenol. The agent features a novel tetrameric molecular structure with high relaxivity, the company said.
The FDA approval is based on the phase III Quanti clinical studies, which found that lesion visualization scores for Ambelvist at its approved dose were similar to those of other mGBCAs dosed at 0.1 mmol Gd/kg in descriptive analyses. Safety and effectiveness were established in pediatric patients including term neonates, supported by pharmacokinetic and safety data from 93 pediatric patients.
Ambelvist carries a boxed warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis, Bayer said. The firm added that it is contraindicated in patients with a history of severe hypersensitivity reactions to the agent.
