Bayer NDA Accepted for Next-Gen Contrast Agent

FDA has accepted a Bayer NDA for gadoquatrane, a next-generation gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). The submission seeks approval for contrast-enhanced MRI of the central nervous system and other body regions in adults and children, including newborns. If approved, gadoquatrane would be the lowest-dose macrocyclic GBCA available in the U.S., delivering 0.04 mmol of gadolinium per kilogram of body weight — a 60% reduction compared with the standard 0.1 mmol/kg dose used in existing macrocyclic agents, according to the company.

The NDA is supported by results from the global Phase 3 QUANTI program, which enrolled more than 800 patients across 15 countries. The studies showed that gadoquatrane met its primary and secondary endpoints for image quality and lesion detection in both adult and pediatric populations, with a safety profile consistent with existing GBCAs and no new safety signals were observed, Bayer says.