NJ-based Mallinckrodt announced that an FDA advisory committee has voted against approval for the company's newly-acquired jaundice drug.
The Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee recommended in a vote of 21 to 3 that the risk-benefit profile of stannsoporfin does not support approval for the treatment of newborns ≥35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe jaundice.
Mallinckrodt bought the drug last year from InfaCare for $80 million upfront, hoping the drug would be a first-in-class pharmacologic treatment for severe jaundice in newborns with a novel mechanism of action that inhibits bilirubin production at its source.
Read the press release