InfaCare’s Stannsoporfin For Jaundice Rebuked By US FDA Panel

04 May 2018

Uncertainties about clinical benefit and neurodevelopmental safety drive lopsided recommendation against approval; some advisory committee members say that even FDA’s REMS proposal wouldn't be enough to allow stannsoporfin to come to market without further studies.

A US FDA advisory committee found little to like in InfaCare Pharmaceutical Corp.’s application for the jaundice drug stannsoporfin May 3, concluding the efficacy and safety data were insufficient to support approval and the sponsor’s proposed voluntary risk mitigation plan was inadequate.

Twenty-one of 24 members of the agency’s gastrointestinal drugs and pediatric advisory committees voted against approval of stannsoporfin, a first-in-class...