- Gadoquatrane's NDA for MRI use is under FDA review, targeting adults and pediatric patients, including neonates.
- The proposed dose is 0.04 mmol Gd/kg, a 60% reduction from standard macrocyclic GBCAs.
- Phase III QUANTI studies involved 808 patients across 15 countries, showing positive efficacy and safety results.
- Regulatory reviews are ongoing in the U.S., Japan, EU, with further applications planned globally.
FDA Review of Gadoquatrane
The U.S. FDA has accepted the New Drug Application for gadoquatrane, a contrast agent for MRI, targeting both adults and pediatric patients, including neonates. If approved, it will be the lowest dose macrocyclic gadolinium-based contrast agent available in the U.S.
Dosage and Benefits
Gadoquatrane is proposed at a dose of 0.04 mmol gadolinium per kilogram body weight, representing a 60% reduction compared to existing macrocyclic GBCAs dosed at 0.1 mmol Gd/kg. This lower dosage is particularly beneficial for patients requiring multiple imaging examinations over their lifetime.
Clinical Trials and Results
The Phase III QUANTI program evaluated gadoquatrane's efficacy and safety in 808 patients across 15 countries. The studies, including QUANTI CNS and QUANTI OBR, met primary and secondary efficacy endpoints, demonstrating effective visualization and lesion detection. The QUANTI Pediatric study confirmed similar pharmacokinetic behavior in children as observed in adults. The safety profile was consistent with previous data, with no new safety signals.
Global Regulatory Status
In addition to the U.S., healthcare authorities in Japan, the European Union, and other countries are reviewing applications for gadoquatrane's marketing authorization. Further regulatory submissions are planned worldwide in the coming months.
