Pharmacologic Tx for Severe Neonatal Jaundice to Be Reviewed by FDA
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for stannsoporfin (Mallinckrodt) for the treatment of neonates at risk for developing severe hyperbilirubinemia. If approved, this would be the first pharmacologic treatment indicated for neonatal jaundice.
The NDA is supported by data from the JASMINE_204 trial. JASMINE_204 was a Phase 2, randomized, double-blind, placebo-controlled parallel group study evaluating the safety and efficacy of 2 doses of stannsoporfin in combination with phototherapy in neonates with hyperbilirubinemia. In addition, a 4-year, blinded outcomes, follow-up study (JASMINE_205) is ongoing; evaluating the long-term effects of stannsoporfin on health, growth, and development of patients who received a single dose of stannsoporfin with phototherapy.
Stannsoporfin, a heme oxygenase inhibitor, works by reducing the production of bilirubin in infants at risk for severe neonatal jaundice. The FDA has set an action date of August 22, 2018 to respond to the NDA; the Agency previously granted the product Fast Track status.
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