FDA Issues CRL for Orviglance NDA - Takeaways - MDSpire

FDA Issues CRL for Orviglance NDA

Ascelia Pharma plans to request a Type A meeting with the FDA following receipt of a Complete Response Letter.

  • By

  • Kathryn Wighton

  • July 6, 2026

  • 2 min

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    The FDA issued a Complete Response Letter for Ascelia Pharma’s New Drug Application for Orviglance.

  • 2

    The FDA requested additional clinical data and product documentation before approving the application.

  • 3

    Ascelia plans to request a Type A meeting with the FDA to understand the issues in detail.

  • 4

    Orviglance is intended for patients with severe kidney impairment needing contrast-enhanced liver MRI.

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    The New Drug Application was based on nine clinical studies, with the phase 3 SPARKLE study meeting its primary endpoint.

Original Source(s)

FDA Issues CRL for Orviglance NDA

  • by Kathryn Wighton

  • July 6, 2026

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