“The letter from the US Food and Drug Administration (FDA) was not unexpected following the outcome of the recent advisory committee meeting,” said Mallinckrodt CSO Steven Romano in a statement.
“We are evaluating the agency’s guidance and will request a meeting with the FDA in the coming months to discuss potential paths forward,” he added.
The firm said it would not be making decisions regarding future efforts or investment in the candidate, until after it speaks with the FDA.
Stannsoporfin is a heme oxygenase inhibitor. “If approved, stannsoporfin would be a first-in-class pharmacologic treatment for severe jaundice in newborns with a novel mechanism of action that inhibits bilirubin [a substance in blood that causes the yellow complexion associated with jaundice], production at its source,” according to Mallinckrodt.
The FDA rejection marks the latest regulatory hurdle for the UK-headquartered firm. In July last year, the US Drug Enforcement Administration (DEA) ordered Mallinckrodt to pay $35m (€30m) to settle allegations of discrepancies between the actual number of tablets manufactured at its oxycodone plant in New York, and the number of tablets the firm reported in its batch records.
The DEA has since proposed an opioid reduction plan to decrease the manufacturing quotas for commonly prescribed opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl.