Bayer Gadoquatrane new drug application accepted for review by USFDA

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.