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Intercept’s NASH Drug Delayed By April Advisory Committee

 
• By Joseph Haas

US FDA sets 22 April for advisory committee review of obeticholic acid in NASH, though whether the extended review was due to scheduling issues or any questions about Intercept's application itself remain unclear.

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Intercept Pharmaceuticals Inc.’s obeticholic acid (OCA) will reach the US market later than initially expected after the US Food and Drug Administration scheduled an advisory committee to review the drug’s new drug application for non-alcoholic steatohepatitis (NASH) on 22 April, nearly a month after its scheduled action date of 26 March.

The company anticipates the agency will grant a 90-day extension to the user fee goal date, it announced 16 December....

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