Bayer Gadoquatrane new drug application accepted for review by USFDA
Berlin: Bayer has announced that a New Drug Application (NDA) for its investigational contrast agent gadoquatrane has been accepted for review by the U.S. Food and Drug Administration (FDA). The NDA for gadoquatrane has been filed for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients, including neonates.
If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent (GBCA) available in the U.S. The submitted dose is 0.04 mmol gadolinium per kilogram body weight, corresponding to a 60 percent reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.
“Chronic diseases like cancer, neurological disorders like multiple sclerosis and cardiovascular conditions are on the rise, leading to an increase in medical imaging. Patients, especially those who require multiple examinations over the course of their lives, can benefit from a reduced contrast media dosage,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division.
Since their introduction in 1988, more than 800 million GBCA doses have been administered worldwide, with an estimated 63 million doses in 2023. Approximately 12-18 million contrast-enhanced MRI scans are performed annually in the United States. 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. Additionally, the healthcare authorities in Japan, the European Union and other countries are currently reviewing applications for marketing authorization for gadoquatrane. Further regulatory applications to health authorities worldwide are planned for the coming months.
MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases.
