Bayer submits gadoquatrane NDA

Bayer has filed a New Drug Application (NDA) requesting U.S. Food and Drug Administration (FDA) approval of its investigational macrocyclic gadolinium-based contrast agent (GBCA) gadoquatrane.

Gadoquatrane is for contrast-enhanced MRI of the central nervous system and other body regions in adults and pediatric patients, including term neonates, at a dose of 0.04 mmol gadolinium per kilogram body weight, according to the company.

Bayer based its NDA submission on positive data from its phase III Quanti studies.

If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the U.S., the company said.