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Intercept’s NASH Drug Delayed By April Advisory Committee, But Firm Is Ready For Launch

 
• By Joseph Haas

Intercept announced that the US FDA has set April 22 as date for an advisory committee review of OCA in NASH, meaning March 26 action date could be pushed back as much as three months.

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An FDA advisory committee for OCA was expected, but scheduling it after the PDUFA date was a surprise

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. That means approval should come in late June, unless the agency acts before the user fee deadline

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