Mallinckrodt plc announced it has successfully completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to seek approval of its recently acquired developmental product stannsoporfin.
If approved, the drug is expected to become the first and only pharmacologic option in the U.S. indicated for the treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.
Stannsoporfin, a heme oxygenase inhibitor, is under investigation for its potential to reduce the production of bilirubin. The safety and effectiveness of stannsoporfin have not yet been established by FDA. If approved, stannsoporfin is expected to be used for late-preterm and full-term infants at risk of developing complications associated with severe jaundice.