Expert Group Says Infocare Drug’s Risk-Benefit Profile Does Not Support Approval

An FDA advisory committee voted Thursday that Infocare’s NDA for stannsoporfin injection’s overall risk-benefit profile does not support the drug’s approval.

In a joint meeting of the Gastrointestinal Drugs and Pediatric Advisory Committees, members voted 21 to 3 against the risk-benefit profile of NDA, proposed for the treatment of neonates at least 35 weeks into gestation with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

Three members voted that the profile supported approval with a REMS, while none voted that it supported approval without a REMS.