Swedish biotech company Ascelia Pharma AB (STO:ACE) said on Wednesday that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Orviglance.

The company is seeking approval for use of the drug as a liver MRI contrast agent in patients with severe kidney impairment.

The submission is supported by nine clinical studies that demonstrated consistent efficacy and safety results.

Orviglance has already received Orphan Drug Designation from the FDA. The therapy is intended to address the unmet need of patients at high risk of developing nephrogenic systemic fibrosis after exposure to gadolinium-based contrast agents. The global market opportunity for this patient group is estimated at USD800m annually.

The FDA's standard review timeline for the application is 10 months.