Bayer has received FDA approval for Ambelvist, a gadolinium-based contrast agent for contrast-enhanced MRI in adult and pediatric patients, including term neonates.
The approval covers detection and visualization of lesions with abnormal vascularity in the central nervous system and body regions including the head and neck, thorax, abdomen, pelvis, and musculoskeletal system.
Ambelvist is the U.S. brand name for gadoquatrane, an intravenous macrocyclic gadolinium-based contrast agent. Bayer said the agent has a tetrameric structure and high relaxivity.
The recommended dose is 0.01 mmol/kg actual body weight. FDA labeling states that each gadoquatrane molecule contains 4 gadolinium ions, meaning the recommended dose delivers 0.04 mmol of gadolinium per kg.
Bayer said the dose represents 60% less gadolinium than macrocyclic GBCAs dosed at 0.1 mmol Gd/kg and 20% less gadolinium than gadopiclenol dosed at 0.05 mmol Gd/kg.
Clinical support came from the phase 3 QUANTI program. FDA labeling states that Ambelvist visualization scores and number of lesions identified per patient were similar to other tested GBCAs in descriptive analyses for CNS and non-CNS body imaging.
Safety was evaluated in 842 patients who received a single 0.01 mmol/kg dose. The population included 697 adults from 2 active-comparator crossover studies, 52 adults from a dose-finding study, and 93 pediatric patients.
Pediatric use is supported by adult efficacy data and additional pharmacokinetic and safety data from 93 pediatric patients aged 28 days to less than 18 years. FDA labeling states that safety has not been established in preterm neonates.
Ambelvist carries a boxed warning for risks associated with intrathecal use and nephrogenic systemic fibrosis. The agent is not approved for intrathecal administration and is contraindicated in patients with a history of severe hypersensitivity reactions to Ambelvist.
Companies:Bayer, U.S. Food and Drug Administration
U.S. Food and Drug Administration coverage
Sources
- DailyMed - AMBELVIST - gadoquatrane injection. Regulatory filing
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