FDA Approves New MRI Contrast Agent for Nervous System Imaging
The FDA approved Bracco Diagnostics’ gadopiclenol injection for use with MRI in adults and pediatric patients, as a contrast agent shortage continues to affect medical imaging in the United States.
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By - A new macrocyclic gadolinium-based contrast agent created by Bracco Diagnostics Inc. gained FDA approval last week after a positive Phase III study. The Vueway injection will be available for adult and pediatric patients undergoing MRIs to detect lesions in the central nervous system.
The agent developed through a collaboration between Bracco and Guerbet demonstrated the highest relaxivity compared to all gadolinium-based contrast agents. A crossover study compared unenhanced MRI images with images of a regular dose of the Vueway injection and those of a .1 mmol/kg Gabodutrol contrast agent to test the product’s effectiveness. All blinded readers participating in the trial preferred the quality of the Vueway images to the two alternatives.
Vueway’s approval follows the Priority Review process, granted for products that present significant improvements in safety and effectiveness. The 0.05 mmol/kg dose demonstrated improvement over unenhanced MRI while violating no major safety signals and recording adverse events similar to alternative contrast agents used in the crossover study.
Approved indications for Vueway use include the brain, spine, head, neck, thorax, pelvis, abdomen, and musculoskeletal system. According to Bracco's safety information, patients with chronic kidney disease, acute kidney injury, or conditions impairing renal function should not be given Vueway, and its use may increase the risk of nephrogenic systemic fibrosis in those patients.
The US approval of Vueway comes on the heels of an FDA decision to grant Bracco import discretion for its contrast agent lomeron.
In August, the FDA decided to allow Bracco to sell lomeron in the US — despite it not being approved — as the worsening shortage of contrast agents threatened to cripple diagnostic imaging capabilities. The acute shortage began when China shut down GE Healthcare manufacturing plants within the country to comply with the “zero COVID” policy.
Around half of the hospitals and imaging centers in the US rely on GE Healthcare contrast agents to conduct the more than 50 million annual imaging examinations that use contrast media. GE reacted to the shutdown of its production in China by increasing production in Ireland and airlifting products into the US. In the meantime, the FDA opened up sales to the Italian Bracco Imaging Llp. and worked to increase supplies.
Independently, researchers found that imaging centers could ration their use of agents by adjusting the amount of contrast per the patient’s weight, and some hospitals have successfully extended their supply by doing so.
For now, the shortage seems to be letting up as the Chinese economy ramps up production again and GE Healthcare’s Shanghai facility stabilizes.
