Bayer seeks USFDA nod for Gadoquatrane for contrast enhanced magnetic resonance imaging of CNS
Berlin: Bayer has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients including term neonates.
The submitted dose is 0.04 mmol gadolinium per kilogram body weight. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the U.S., corresponding to a 60 percent reduction compared to standard of care macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.
The submission of gadoquatrane to the U.S. FDA is based on positive data from the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane in adult and pediatric patients globally. The first results from the Phase III QUANTI CNS study were presented at the European Congress of Radiology (ECR) in February of this year and further results are planned to be presented at upcoming scientific meetings.
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