Two of the biggest players in the medical imaging contrast market are teaming up on a “next-generation” material for magnetic resonance imaging exams.
Guerbet and Bracco announced plans to commercialize a macrocyclic gadolinium-based contrast known as Gadopiclenol on Tuesday, December 14. Multiple Phase 3 studies released in March showed the contrast is safe and effective while requiring 50% less gadolinium compared to other commonly used agents.
“Gadopiclenol represents real and valuable innovation in MRI, with a unique profile of stability and contrast enhancement properties that will allow a low dose to be effectively used in a large number of clinical settings and clinical indications,” Bracco Imaging CEO Fulvio Renoldi Bracco said Tuesday.
Villepinte, France-based Guerbet will manufacture the contrast agent’s active ingredient for Bracco. After seven years, both companies will have the right to manufacture the imaging agent.
The pair said it plans to gather data and begin seeking regulatory approval in the U.S. and European Union early next year. They expect the first U.S. marketing authorizations to occur in 2023.
“Our ambition is to make this available to as many patients as soon as possible,” David Hale, CEO of Guerbet, said in a statement. “This is a bold decision which will accelerate our ability to further develop Gadopiclenol, which will bring significant health benefits worldwide.”
Read the full announcement here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.