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Drugs For Severe Hyperbilirubinemia Could Face Long Development Program

 
• By Cathy Dombrowski

FDA’s Gastrointestinal Drugs Advisory Committee notes difficulty in identifying endpoint during a March 13 meeting to discuss potential drug development pathways for the disease.

The length of time that would be needed to conduct the safety study suggested as appropriate during an FDA advisory committee meeting highlights the difficulty of conducting clinical trials for a therapy to treat or prevent severe hyperbilirubinemia in neonates.

Neurocognitive effects can appear quite late into childhood, necessitating follow-up to age seven, David Bellinger, a Harvard professor of neurology, suggested during the Gastrointestinal Drugs Advisory Committee’s March 13 meeting.

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