The research included 24 participants, some of whom fasted before having an MRI exam and others who had a light or full meal. It demonstrated that image enhancement with the agent is not affected by a patient having a light meal before undergoing MRI, the company said.
Ascelia plans to include this data in a new drug application (NDA) it will submit to the U.S. Food and Drug Administration (FDA). The FDA has granted Orviglance Orphan Drug Designation, according to the firm.
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