FDA Accepts Gadoquatrane New Drug Application

Bayer 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 central nervous system (CNS) and other body regions in adults and pediatric patients, including neonates.

Gadoquatrane is Bayer’s investigational extracellular macrocyclic contrast agent in clinical development for contrast enhancement in MRI. This low-dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity.

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.

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 pivotal QUANTI clinical development program 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 multinational, randomized, prospective double-blind, crossover Phase III studies – QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) – as well as the QUANTI Pediatric study. 

A total of 808 patients in 15 countries participated in the program. The QUANTI study results show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that observed in adults.

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.

“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.