FDA rejects Mallinckrodt's filing for jaundice therapy stannsoporfin

Mallinckrodt on Wednesday confirmed that it received a complete response letter from the FDA regarding a filing seeking approval of stannsoporfin for use in newborns at risk of jaundice. The drugmaker said the agency "provided guidance" concerning areas of further evaluation for resubmitting the therapy, which is being developed for the prevention of hyperbilirubinaemia in newborns at least 35 weeks of gestational age with indicators of haemolysis. 

The complete response letter had been expected after Mallinckrodt said in May that an FDA advisory committee voted 21-3 that the risk-benefit profile of stannsoporfin did not support approval. The drugmaker noted that the haem oxygenase inhibitor would have been a first-in-class therapy for severe jaundice in newborns with a mechanism of action that inhibits bilirubin production at its source. 

Chief scientific officer Steven Romano stated "we are evaluating the agency's guidance and will request a meeting with the FDA in the coming months to discuss potential paths forward." Mallinckrodt also indicated that it does not anticipate making a decision about future efforts or investment regarding the development of stannsoporfin prior to its discussions with the FDA. 

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