FDA approves macrocyclic GBCA for contrast-enhanced MRI

The FDA has approved Elucirem, a macrocyclic gadolinium-based contrast agent for those aged 2 years and older, for use in contrast-enhanced MRIs

The product, Guerbet’s gadopiclenol, was approved following priority review and is used to detect and visualize lesions with abnormal vascularity in the central nervous system and the body.

According to a press release from Guerbet, the active substance in Elucirem — gadopiclenol — has been designed with two sites for water molecule exchange to increase relaxivity and contrast. This results in half the conventional dose of gadolinium to be required, compared with other non-specific gadolinium-based contrast agents (GBCAs).

“As a pioneer in MR imaging, thanks to the success of our first gadolinium-based macrocyclic contrast agent, we are delighted with the FDA approval of Elucirem,” Guerbet CEO David Hale, said in a press release from the company. “This approval allows patients and practitioners to benefit from the innovations brought by Elucirem.”

The efficacy and safety of Elucirem was assessed as part of the company’s clinical development plan, with marketing authorization being targeted globally. Two phase 3 studies that were completed in March demonstrated Elucirem leads to noninferior results in brain and body MRI at half the dose of gadolinium.

No major safety signals were reported during the development of Elucirem.