The US Food and Drug Administration (FDA) has accepted Bayer’s New Drug Application (NDA) for its investigational contrast agent gadoquatrane. The NDA has been filed for contrast-enhanced Magnetic Resonance Imaging of the Central Nervous System (CNS) and other body regions in adults and paediatric patients, including neonates.

If approved, gadoquatrane would become the lowest dose macrocyclic Gadolinium-Based Contrast Agent (GBCA) available in the US. 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 and Development, Pharmaceuticals Division, Bayer.

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 US FDA is based on positive data from the pivotal Phase-III QUANTI studies evaluating the efficacy and safety of gadoquatrane in adult and paediatric patients, globally. Additionally, the healthcare authorities in Japan, the European Union and other countries are currently reviewing applications for marketing authorisation for gadoquatrane. Further, regulatory applications to health authorities worldwide are planned for the coming months.

The QUANTI clinical development programme investigated gadoquatrane at a dose of 0.04 mmol Gd/kg body weight, which represents a 60 percent lower gadolinium dose compared to macrocyclic contrast agents dosed at 0.1 mmol Gd/kg body weight.

QUANTI consisted of two large multi-national, randomised, prospective double-blind, crossover Phase-III studies–QUANTI CNS and QUANTI OBR (Other Body Regions) – as well as the QUANTI Paediatric study. In total, 808 patients in 15 countries participated in the programme. The QUANTI study results show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualisation parameters and lesion detection. Results of QUANTI Paediatric demonstrated that the pharmacokinetic behaviour of gadoquatrane in children is similar to that observed in adults.

The observed safety profile in adults as well as paediatric patients from birth to < 18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed.

With first results from the Phase-III QUANTI CNS study revealed at the European Congress of Radiology (ECR) in February of this year, further study data are planned to be presented at upcoming scientific meetings.