Mallinckrodt “expressed disappointment” that, in a joint meeting, the U.S. Food and Drug Administration's (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 ≥35 weeks of gestational age with indicators of hemolysis who are at risk of developing hyperbilirubinemia (severe jaundice).
In a statement released by the company, 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 today's meeting, the company is evaluating alternatives for this development program.”