Shots:
- The US FDA has approved Ambelvist (gadoquatrane) for contrast-enhanced MRI to detect lesions with abnormal vascularity in the CNS and other body regions in adults and pediatric patients, including term neonates
- Approval was supported by the global P-III (QUANTI) studies, which demonstrated that Ambelvist improved lesion visualization at a lower gadolinium dose (0.04 mmol Gd/kg) while providing diagnostic performance comparable to conventional macrocyclic GBCAs dosed at 0.1 mmol Gd/kg. Its safety and efficacy were established in both adults and pediatric patients, including term neonates, supported by clinical, pharmacokinetic, and safety data from 93 pediatric patients (Aged:28 days to <18 yrs)
- Ambelvist is a gadolinium-based contrast agent indicated for contrast-enhanced MRI in adults and pediatric patients, including term neonates, to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine, and associated tissues) and non-CNS body regions (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)
Ref: Bayer | Image: Bayer |Press Release
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