Stannsoporfin

Unassigned

New Medicines

Neonatal jaundice

Information

New molecular entity
Mallinckrodt
Mallinckrodt

Development and Regulatory status

None
None
Not approved

Aug 18: The FDA had agreed to consider a filing based on PIIb trials in 2016. Mallinckrodt will now meet with the FDA to discuss potential paths forward in the coming months [4].


Aug 18: Not approved by US FDA. A complete response letter outlining areas of further evaluation to be considered before resubmitting an application for approval of the first-in-class heme oxygenase inhibitor has been issued [3].


Aug 18: This was filed in the US. FDA have set an action date of August 18 for stannsoporfin for the treatment of neonates at risk for developing severe jaundice (hyperbilirubinemia). [2]


Aug 18: The drug received Fast Track status. [2]

Category

Competitive haem oxygenase inhibitor
Approximately 60% of term and 80% of preterm babies develop jaundice in the first week of life; about 10% of breast-fed babies are still jaundiced at 1 month of age [5].
Neonatal jaundice
Intramuscular

Trial or other data

Mar 16: PII JASMINE_204 study (NCT01887327) to evaluate two doses of stannsoporfin in combination with phototherapy in 91 infants in the US completes [6].


Feb 13: PIII study (NCT02685137) to assess a single intramuscular injection of stannsoporfin compared to "sham" (placebo) in 185 healthy term and near-term newborns admitted to the well-baby nursery in the US completes [6].


PIII trials expected to start 2009, after InfaCarepharma secured $28M to advance development for neonatal hyperbilirubinaemia (1).