Bayer seeks gadoquatrane approval in China

The Center of Drug Evaluation of China’s National Medical Products Administration has accepted Bayer's new drug application for its low-dose contrast agent, gadoquatrane. 

The investigational gadolinium-based agent is intended for contrast enhancement in MR imaging to detect and visualize known or suspected pathologies in all body regions and the central nervous system in adults and pediatric patients including neonates. 

The submitted dose of 0.04 mmol gadolinium per kilogram body weight represents a gadolinium dose reduction of 60% compared to the standard of care macrocyclic contrast agents dosed at 0.1 mmol Gd/kg body weight, Bayer said.

The company based its submission of gadoquatrane in China on data from the global phase III Quanti studies, which also included Chinese patients. These studies evaluated the efficacy and safety across a broad range of indications in adult and pediatric patients. 

This submission follows Bayer filing marketing authorization requests in Japan, the U.S., and the European Union (EU), it said. The company is planning regulatory applications to health authorities around the world.