1. Pink Sheet

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

 
• By Derrick Gingery

There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.

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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.

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