German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) said on Monday that it has received US Food and Drug Administration (FDA) approval for AMBELVIST (gadoquatrane), an intravenous macrocyclic gadolinium-based contrast agent indicated for contrast-enhanced MRI to detect and visualise lesions with abnormal vascularity in central nervous system (CNS) and non-CNS body regions in adult and paediatric patients, including term neonates.

According to Bayer, AMBELVIST is the lowest-dose macrocyclic gadolinium-based contrast agent approved in the United States, with a recommended dose of 0.01 mmol/kg actual body weight, delivering 0.04 mmol gadolinium/kg body weight.

Approval was supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a lower gadolinium dose than contrast agents administered at 0.1 mmol gadolinium/kg body weight. The studies showed increased lesion visualisation when pre-contrast and post-contrast MRI images were combined, while lesion visualisation scores and lesion detection rates were similar to those observed with tested macrocyclic gadolinium-based contrast agents containing 0.1 mmol gadolinium/kg body weight.

Bayer said the safety and effectiveness of AMBELVIST have been established for use in adults and paediatric patients, including term neonates, with supporting pharmacokinetic and safety data from 93 paediatric patients.

AMBELVIST carries a boxed warning related to risks associated with intrathecal administration and nephrogenic systemic fibrosis and is contraindicated in patients with a history of severe hypersensitivity reactions to the product.