The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Bracco's Vueway agent (gadopiclenol) for MR imaging of the central nervous system.
The recommendation is based on results from two clinical studies, PICTURE and PROMISE, Bracco said. The European Commission will take the recommendation into account and issue a decision by the end of the year, Bracco said.
Vueway was cleared by the U.S. Food and Drug Administration in September 2022.
