InfaCare’s Jaundice Drug Stannsoporfin Brings Efficacy, Safety Questions Into US FDA Panel

 
• By Sue Sutter

Whether the single pivotal trial provides ‘substantial and highly persuasive evidence of effectiveness’ is a key question for advisory committee, although FDA also seeks advice on adequacy of the data to characterize adverse neurodevelopment outcomes; if approved, the heme oxygenase inhibitor could face a restrictive Risk Evaluation and Mitigation Strategy.

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InfaCare Pharmaceutical Corp.’s jaundice drug stannsoporfin comes into a US FDA advisory committee review facing a host of agency questions, including adequacy of the lone pivotal trial to support approval, potential risk of adverse neurodevelopmental outcomes, and need for a restrictive Risk Evaluation and Mitigation Strategy (REMS).

FDA’s gastrointestinal drugs and pediatric advisory committees will meet jointly May 3 to consider the use of stannsoporfin for treatment of neonates greater than or equal to 35 weeks of...

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