To inform about the FDA's Complete Response Letter regarding Ascelia Pharma's New Drug Application for Orviglance.
Approach:
FDA Response: The FDA issued a Complete Response Letter indicating that the application could not be approved in its current form and requested additional clinical data and product documentation.
Company's Next Steps: Ascelia Pharma plans to request a Type A meeting with the FDA to understand the issues in detail and aims to identify an expedited path forward.
Key Findings:
Orviglance is developed for patients with severe kidney impairment requiring contrast-enhanced liver MRI.
The New Drug Application was submitted in September 2023 and accepted for FDA review in November 2023.
The FDA assigned a target action date of July 3, 2024.
The application was based on a development program that included nine clinical studies with positive efficacy and safety results.
The phase 3 SPARKLE study met its primary endpoint, showing significant improvement in visualization of focal liver lesions.
A Korean cohort study found fewer kidney cancer cases among patients with type 2 diabetes who initiated sodium-glucose cotransporter 2 inhibitors vs dipeptidyl peptidase-4 inhibitors.
