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Ascelia Pharma Announces FDA Acceptance of Orviglance New Drug Application for Review
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| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Läkemedel & Handel |
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Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Orviglance® for review. The FDA has set an action date of 3 July 2026 under the Prescription Drug User Fee Act (PDUFA).
The FDA has confirmed through their ‘day 74 letter’ their acceptance of the NDA filing for Orviglance and continuation of the review aiming for a decision by 3 July 2026 as the PDUFA date.
“This milestone represents yet another significant step towards our goal of making Orviglance available to cancer patients with impaired kidney function. We look forward to continuing to work with the FDA throughout the review process,” said Magnus Corfitzen, CEO of Ascelia Pharma. “The FDA filing acceptance is also important for our discussions with potential commercialization partners”.
The NDA submission is based on the successful completion of the development program, which includes nine clinical studies with consistent positive efficacy and safety results. 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 the FDA for 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 (NSF) after exposure to the gadolinium-based contrast agents normally used today. Regulatory bodies have issued warnings for the use of these agents in this vulnerable patient population. Orviglance aims to give patients with impaired kidney function access to safe and effective liver imaging. The unmet need for these patients represents a global annual addressable market potential of USD 800 million.