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# ‘Complete Response’ on Liver Imaging Agent
- URL: https://www.fdaweb.com/complete-response-on-liver-imaging-agent/
- Published: 2026-07-06T12:00:00.000Z
- Updated: 2026-09-14T13:42:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161408

FDA has issued Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging. The company says the letter is requesting additional clinical data and product documentation. “We seek to understand the issues in detail and plan to request a Type A meeting with the FDA as soon as possible,” it says.

The NDA submission is based on data from nine clinical studies with “consistent positive efficacy and safety results,” according to the company. “In the Phase 3 study, SPARKLE, Orviglance significantly improved visualization of focal liver lesions in patients with impaired kidney function, meeting the primary endpoint with statistical significance (<0.001).”

Orviglance has been granted an Orphan Drug Designation by FDA for its use as a contrast agent for liver MRI in patients with severely impaired kidney function. These patients have the highest risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis after exposure to the gadolinium-based contrast agents normally used, the company says.