Ascelia Pharma says FDA points to new SPARKLE prospective image analysis as potential Orviglance approval path

• Ascelia Pharma said the FDA maintained that approval of its Orviglance New Drug Application would require additional clinical evidence from a new clinical study.
• The agency also signaled that support for approval could potentially come from a prospective analysis of Phase 3 SPARKLE images using a different primary endpoint.
• The company said it does not plan to run another Orviglance clinical study.
• It will instead review U.S. options that rely on the existing SPARKLE dataset while advancing European regulatory work and partnering.
• No new clinical results were presented in the update.

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