Mallinckrodt completes Stannsoporfin new drug application filing
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.
"We are pleased to complete this important milestone for stannsoporfin," said Steve Romano, M.D., Chief Scientific Officer and Executive Vice President of Mallinckrodt. "This brings us one step closer to addressing an unmet need for therapies to treat thousands of infants at risk for severe jaundice, and we look forward to working closely with the FDA toward the goal of obtaining approval of stannsoporfin to treat this population."
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.
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