FDA approves Bayer's new low-dose gadolinium imaging agent
Earlier this week, the U.S. Food and Drug Administration approved the lowest dose macrocyclic gadolinium-based contrast agent (GBCA) to date.
Ambelvist, or gadoquatrane, is an intravenous macrocyclic GBCA indicated for contrast-enhanced MRI of the central nervous system and other non-CNS body regions in adults and children. Coming in at just 0.04 mmol Gd/kg, gadoquatrane delivers 60% less gadolinium than conventional GBCAs dosed at 0.1 mmol Gd/kg and 20% less gadolinium than gadopiclenol, which is dosed at 0.05 mmol Gd/kg. The agent was designed to have a novel tetrameric structure and high relaxivity, making it an optimal GBCA alternative suitable for maintaining image quality.
The approval comes following positive results from the QUANTI clinical studies, which tested the agent’s safety and efficacy in adults and children. That trial has consistently highlighted the agent’s potential for improving the visualization of lesions with abnormal vascularity in the CNS and body, while also being well tolerated by patients as young as 28 days.
“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,” Jill Carbone, VP and head of radiology, North America Product and Pipeline, said in a statement June 15. “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.”
“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," added Christopher Hancock, MD, MBA, director of neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI study, said in an announcement.
The New Drug Application for Ambelvist was approved by the FDA in August. Its safety and efficacy also are under review in Japan, the European Union and other countries, where Bayer has submitted applications for marketing authorization.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.