Ascelia Pharma
Ascelia Pharma Submits Orviglance New Drug Application to the U.S. Food and Drug Administration
Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the New Drug Application (NDA) for Orviglance® has been submitted to the US Food and Drug Administration (FDA).
The NDA for Orviglance has been submitted to the FDA. Ascelia Pharma seeks marketing approval for Orviglance as liver MRI contrast agent for patients with severe kidney impairment. The submission is based on the successful completion of the development program, including nine clinical studies with consistent positive efficacy and safety results.
“We are delighted to announce the submission of the NDA for Orviglance. This is a significant achievement for Ascelia Pharma”, said Magnus Corfitzen, CEO of Ascelia Pharma. “We now look forward to advancing Orviglance through the FDA review process.”
The FDA standard review timeline is 10 months.
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.
| Datum | 2025-09-03, kl 10:10 |
| Källa | MFN |
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