LEVERKUSEN (dpa-AFX) - Bayer AG (BYR.L) said on Monday that the U.S. Food and Drug Administration approved Ambelvist, a new intravenous macrocyclic gadolinium-based contrast agent for use in contrast-enhanced magnetic resonance imaging (MRI) scans.
The drug is indicated for detecting and visualizing lesions with abnormal vascularity throughout the body, including the central nervous system, in adult and pediatric patients.
The approval was supported by data from the Phase III QUANTI studies, which demonstrated the agent's efficacy at a substantially lower dose than macrocyclic gadolinium-based contrast agents.
Bayer said the approval makes Ambelvist the lowest-dose macrocyclic gadolinium-based contrast agent available in the United States. The recommended dose is 0.01 mmol/kg of actual body weight, delivering 0.04 mmol of gadolinium per kilogram.
According to the company, this represents 60% less gadolinium than macrocyclic contrast agents containing 0.1 mmol gadolinium per kilogram and 20% less gadolinium than gadopiclenol, which contains 0.05 mmol gadolinium per kilogram.
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