First production batch of Elucirem injection has been released for use after FDA approval
Guerbet has announced the first production batch has been manufactured and released for Elucirem™ injection following FDA approval on September 21, 2022. Elucirem™ (Gadopiclenol) will be produced in the United States and France. This next generation GBCA from Guerbet is indicated for use in adults and children aged 2 years and older.
“We are in the process of distributing the first batch of Elucirem™ to our partners and are eager to get this digital imaging innovation in the hands of physicians across the county,” says Jared Houk, commercial vice president, North America at Guerbet. “Releasing the first batch from our production facility in North Carolina is an important moment for everyone at Guerbet and we are proud to see the hard work and dedication come to fruition.”
Elucirem™ (Gadopiclenol) injection is used to detect and visualize lesions with abnormal vascularity in the central nervous system, brain, spine, and associated tissues, and the body’s head and neck, thorax, abdomen, pelvis, and musculoskeletal system. In the approved indications, a contrast-enhanced MRI examination using Elucirem™ requires half the gadolinium dose of existing non-specific GBCAs (gadolinium-based contrast agents), addressing practitioners’ concerns about gadolinium exposure.
GBCAs improve the contrast between lesions and surrounding tissues by accelerating the relaxation of protons thanks to interaction with gadolinium atoms. Gadopiclenol, the active drug substance of Elucirem™, has been designed to enable twice as much interaction. This allows use at half the conventional gadolinium dose to reveal high quality images.
Elucirem is manufactured by Liebel-Flarsheim™ Company LLC, a Guerbet Group company, in Raleigh, North Carolina and is now available for order.
