1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

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.

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers