The US Food and Drug Administration issued a Complete Response Letter for Ascelia Pharma’s New Drug Application for Orviglance, according to a press release from the company. Ascelia said the FDA informed the company that it could not approve the application in its current form and requested additional clinical data and product documentation.

Ascelia said it plans to request a Type A meeting with the FDA as soon as possible to better understand the issues in detail. The company said its focus is to work with the FDA to identify an expedited path forward.

Magnus Corfitzen, CEO of Ascelia Pharma, said in the press release, “We remain confident in Orviglance and are committed to making it available to patients.”

Orviglance is being developed for patients with severe kidney impairment who require contrast-enhanced liver magnetic resonance imaging.

According to Ascelia Pharma company materials, the New Drug Application was submitted in September 2025 and accepted for FDA review following receipt of a Day 74 letter in November 2025. The FDA assigned a Prescription Drug User Fee Act target action date of July 3, 2026.

The company reported that the New Drug Application was based on a development program that included nine clinical studies with positive efficacy and safety results. Ascelia also reported that the phase 3 SPARKLE study met its primary endpoint, with Orviglance significantly improving visualization of focal liver lesions in patients with impaired kidney function for all three readers.

Ascelia said it will provide additional updates as appropriate.

Source: Ascelia Pharma