FDA Committees Vote Against Drug Tx for Severe Neonatal Jaundice

Stannsoporfin, a heme oxygenase inhibitor, works by inhibiting bilirubin production at its source
Stannsoporfin, a heme oxygenase inhibitor, works by inhibiting bilirubin production at its source

Mallinckrodt announced that the Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee voted against (21-3) the approval of stannsoporfin, a treatment for newborns ≥35 weeks of gestational age with indicators of hemolysis who are at risk for developing hyperbilirubinemia, stating that the risk/benefit profile of the drug does not support approval.

Stannsoporfin, a heme oxygenase inhibitor, works by inhibiting bilirubin production at its source. The accepted NDA included data from the Phase 2, randomized, double-blind, placebo-controlled, parallel-group JASMINE_204 trial which evaluated the safety and efficacy of 2 doses of stannsoporfin in combination with phototherapy in neonates with hyperbilirubinemia. An ongoing 4-year follow-up study JASMINE_205, is currently evaluating the long-term effects of stannsoporfin on health, growth, and development of patients who received a single dose of stannsoporfin with phototherapy. 

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While the FDA is not bound to the Committees' vote, their input is taken into consideration when reviewing marketing applications.The FDA had originally set a target Prescription Drug User Fee Act (PDUFA) date for August 22, 2018. If approved, stannsoporfin would be a first-in-class pharmacologic treatment for severe jaundice in newborns. 

At this time, the Company is looking into alternatives for this development program. 

For more information visit Mallinckrodt.com.