Bayer new drug application for gadoquatrane accepted for review in China

Berlin: Bayer today announced that the Center of Drug Evaluation of China's National Medical Products Administration has accepted the new drug application for gadoquatrane.

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

If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in China. The submitted dose of 0.04 mmol gadolinium per kilogram body weight represents a gadolinium dose reduction of 60 percent compared to the standard of care macrocyclic contrast agents dosed at 0.1 mmol Gd/kg body weight.

“Magnetic resonance imaging is essential for informing and guiding treatment decisions, as evidenced by the increasing number of MRI procedures globally, including China,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division. “With this submission, we seek to advance gadoquatrane as a potential low dose contrast agent option for MRI. This commitment aligns with recommendations from radiological societies in addition to European health authority guidance to use the minimum dose necessary to acquire the needed clinical information.”

Patients, particularly those with chronic conditions who need multiple contrast-enhanced MRI scans over their lifetime, can benefit from a reduction in dosage. In China, approximately 16 million contrast-enhanced MRI scans are performed annually, with a growth rate of 15% in recent years.

The submission of gadoquatrane in China is based on positive data from the global pivotal Phase III QUANTI studies, which also included Chinese patients, evaluating the efficacy and safety across a broad range of indications in adult and pediatric patients. Additionally, the healthcare authorities in Japan, the U.S., 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.