FDA advisory committee rejects stannsoporfin, a treatment of neonates at risk for developing severe hyperbilirubinemia.- Mallinckrodt.

Mallinckrodt plc expressed disappointment that, in a joint meeting, the FDA's 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 greater than 35 weeks of gestational age with indicators of hemolysis who are at risk of developing hyperbilirubinemia (severe jaundice).

Mallinckrodt appreciates the committees' review and discussion of stannsoporfin, and will work closely with the FDA as the review process continues. Given the outcome of the meeting, the company is evaluating alternatives for this development program.