Ascelia Pharma receives conditional FDA acceptance for brand name Orviglance

2021-08-10
Download

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted Orviglance® as the proposed brand name for manganese chloride tetrahydrate (Mangoral), the company's novel first-in-class MRI contrast agent for use in liver MR imaging in adults with severely impaired kidney function.

The name Orviglance was developed in accordance with FDA’s guidance for the submission and evaluation of proprietary names and the name selection included a research study of healthcare practitioners across the U.S. to ensure accurate prescription and safety interpretation of the name.

In addition, Orviglance previously received an invented name approval from the European Medicines Agency (EMA).

 “This is yet another important step towards making Orviglance available to patients as our U.S. and global commercialization preparations progress. We continue to focus on the completion of the ongoing Phase 3 program and subsequent regulatory submission, approval and launch of this first-in-class MRI contrast agent”, said Julie Waras Brogren, Chief Commercial Officer of Ascelia Pharma.

Orviglance (previously referred to as Mangoral), which entered pivotal clinical studies in 2020, has been granted an Orphan Drug Designation (ODD) by the FDA and is targeted patients with poor kidney function who undergo an MRI scan of the liver to detect cancer.

As part of the launch plans for Orviglance*, Ascelia Pharma opened its US office in New Jersey earlier this year.

*Trademark is registered in Europe and several other markets and submitted for registration in the US.