Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval

Bayer’s latest take on a gadolinium-based contrast agent (GBCA) is one step closer to achieving clearance from the U.S. Food and Drug Administration. 

On Monday the health sciences giant shared that the FDA had approved the company’s New Drug Application for its investigational GBCA, gadoquatrane. It will now go through the regulatory review process on its trek to earning full FDA approval. 

Gadoquatrane is a low-dose GBCA that was developed for imaging of the central nervous system and other body regions in both adults and children. Coming in at just 0.04 mmol gadolinium per kilogram body weight, gadoquatrane has 60% less gadolinium in it than the lowest dose GBCA currently on the market. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the U.S. 

Konstanze Diefenbach, MD, head of radiology research and development for Bayer, is hopeful the new agent will address the growing demand for contrast-enhanced MR imaging. 

“Chronic diseases like cancer, neurological disorders like multiple sclerosis and cardiovascular conditions are on the rise, leading to an increase in medical imaging,” Diefenbach said in an announcement. “Patients, especially those who require multiple examinations over the course of their lives, can benefit from a reduced-contrast media dosage.” 

Clinical trials testing the agent thus far have yielded positive results. The phase 3 QUANTI study has been evaluating the agent’s safety and efficacy in adult and pediatric populations undergoing imaging of the CNS. The extracellular macrocyclic agent is said to have a distinct tetrameric structure with high stability and high relaxivity. So far, it has achieved both primary and secondary endpoints at the lower dose while also meeting the diagnostic standards of radiologists. 

Outside the U.S., gadoquatrane’s safety and efficacy is also under review in Japan, the European Union and other countries, where Bayer has submitted applications for marketing authorization for the GBCA. 

Learn more about gadoquatrane’s performance in clinical trials here.