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.
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.
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