Will A US FDA Advisory Committee Be In Intercept's Future?

 
• By Derrick Gingery

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Liver infection
Several factors point toward the FDA making the product one of the minority of applications receiving an advisory committee meeting in 2019. • Source: Shutterstock

Intercept Pharmaceuticals Inc.'s obeticholic acid (OCA) application for approval in non-alcoholic steatohepatitis (NASH) faces two big review hurdles before the US Food and Drug Administration decides whether the drug can cross the approval finish line.

The first is whether it will be granted priority review. The candidate has a breakthrough designation, which bodes rather well,...

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