Bayer seeks FDA approval for gadoquatrane, its latest low-dose GBCA
Bayer has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its latest gadolinium-based contrast agent.
In an announcement, the pharmaceutical giant revealed the move comes after positive clinical trial results for its investigational GBCA gadoquatrane. The phase 3 QUANTI study has been evaluating the agent’s safety and efficacy in adult and pediatric populations undergoing imaging of the central nervous system (CNS).
Gadoquatrane uses 60% less gadolinium without sacrificing image quality, according to recent findings from the trial. 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.
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 that uses lower dosages.
“As a leader in radiology, we are committed to advancing innovation in this field, including options to reduce the gadolinium dose," Diefenbach said in the announcement. "Patients can benefit from a dose reduction, especially patients with chronic conditions who require multiple contrast-enhanced MRI examinations during their lifetime."
The announcement comes as experts have voiced concern about the availability of gadolinium due to trade tensions between the U.S. and China. In April, China announced retaliatory restrictions on the exportation of several rare-earth materials, including gadolinium, in response to tariffs. Despite a recent 90-day trade truce with the U.S., China is still keeping a tight leash on its rare-earth exports, potentially to maintain some leverage in future trade negotiations.
Bayer also is seeking authorization for gadoquatrane in Japan and recently shared the company had submitted an application to do so to the Ministry of Health, Labour, and Welfare there.
Learn more about gadoquatrane’s performance in clinical trials here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.