Ascelia Pharma AB (publ) (ticker: ACE), a biotechnology company specializing in rare cancer treatments, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Orviglance.
Orviglance is designed as a liver magnetic resonance imaging (MRI) contrast agent specifically for patients with significantly impaired kidney function. This population faces a heightened risk of developing nephrogenic systemic fibrosis (NSF), a serious and potentially fatal condition, when exposed to currently available gadolinium-based contrast agents.
The NDA submission is a significant milestone, based on the successful completion of nine clinical studies. These studies consistently demonstrated positive efficacy and safety results.
Magnus Corfitzen, CEO of Ascelia Pharma, expressed his satisfaction with the NDA submission. He indicated the company is now focused on navigating the FDA review process. The standard review period is typically ten months.
Orviglance has already received Orphan Drug Designation from the FDA. This designation recognizes the drug’s potential to address a significant unmet need in a small patient population. The global market potential for this treatment is estimated at $800 million annually.
The company’s commitment is to provide patients with impaired kidney function access to safe and effective liver imaging. Existing gadolinium-based contrast agents carry substantial risk for this patient group, leading to regulatory warnings against their use.
Ascelia Pharma is a biotech company focused on orphan oncology treatments. The company’s pipeline includes two drug candidates in clinical development: Orviglance and Oncoral. Ascelia Pharma is headquartered in Malmö, Sweden, and is listed on Nasdaq Stockholm.
Orviglance, containing manganese chloride tetrahydrate, is an oral contrast agent. It’s designed to improve the detection and visualization of liver lesions in patients with reduced kidney function. The pivotal Phase 3 study, SPARKLE, contributed significantly to the NDA submission.
Ascelia Pharma‘s management team, including Magnus Corfitzen and Julie Waras Brogren, are available for further inquiries regarding this significant regulatory milestone.
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