Bayer has received approval from Japan's Ministry of Health, Labour, and Welfare for gadoquatrane, a low-dose macrocyclic gadolinium-based contrast agent (GBCA) marketed as Ambelvist.
Gadoquatrane is the first low-dose MRI contrast agent available in Japan, Bayer noted. It is indicated for detecting and visualizing pathologies in all body regions and the central nervous system in adult and pediatric patients, including newborns.
Gadoquatrane delivers a gadolinium dose of 0.04 mmol/kg body weight -- 60% less than other macrocyclic GBCAs currently on the Japanese market -- while maintaining diagnostic image quality, according to Bayer.
The approval was based on results from gadoquatrane’s clinical program, including the phase III QUANTI studies and a phase I/III pediatric study. The QUANTI program included CNS studies as well as other body regions.
Findings showed similar visualization scores for gadoquatrane compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg, Bayer said. The pediatric and adult studies demonstrated similar pharmacokinetic and safety findings.
Bayer has also submitted marketing authorization applications in other markets, including the U.S., EU, and China.
With these approvals, gadoquatrane would be the lowest dose macrocyclic gadolinium-based contrast agent available on the respective markets, the company added.
