U.S. FDA accepts Bayer’s NDA for MRI contrast agent

The U.S. Food and Drug Administration (FDA) has accepted Bayer’s New Drug Application (NDA) for its investigational MRI contrast agent gadoquatrane.

If approved, gadoquatrane would become the lowest-dose GBCA available in the U.S., according to the company. The submitted dose is 0.04 mmol Gd/kg body weight, corresponding to a 60% reduction compared to macrocyclic gadolinium-based contrast agents dosed at 0.1 mmol Gd/kg body weight, the company said.

The NDA acceptance is supported by a phase II trial that demonstrated strong efficacy and safety across adult and pediatric patients, including neonates. Regulatory reviews are also underway in Japan, Europe, and other countries, Bayer noted.