By Fineline Cube 
Germany-based Bayer AG (ETR: BAYN) announced that it has made a New Drug Application (NDA) filing with the US Food and Drug Administration (FDA) for its novel contrast agent gadoquatrane. The proposed indication covers contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other body regions in adults and pediatric patients, including full-term neonates.
Dosage and Market Position
The recommended dosage is 0.04 millimoles of gadolinium per kilogram of body weight (mmol Gd/kg). If approved, gadoquatrane would become the lowest-dose macrocyclic gadolinium-based contrast agent (GBCA) available in the U.S. market, offering a 60% reduction in gadolinium dose compared to conventional macrocyclic GBCAs (typically dosed at 0.1 mmol Gd/kg).
Clinical Trial Results
The filing is supported by positive results from the pivotal Phase III QUANTI trial. The trial evaluated the efficacy and safety of gadoquatrane in global adult and pediatric populations. Data demonstrated that gadoquatrane met all primary and secondary efficacy endpoints for visualization parameters and lesion detection, with no new safety signals observed.-Fineline Info & Tech