FDA rejects Orviglance oral MRI contrast agent application due to reader concerns

FDA rejected Ascelia Pharma’s Orviglance, an oral manganese-based MRI contrast for focal liver lesions, because only 1 of 3 initial readers showed superiority of contrasted over noncontrast images. The agency recommends a new controlled study with rigorous reader training.

• The pivotal trial failed because only 1 of 3 initial readers saw a benefit; subsequent reader training after knowing results introduced potential bias.
• Ascelia Pharma maintains the study was adequate and has adopted independent blinded readers; it will meet with the FDA to discuss next steps.

Automated summary

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