Intercept provides regulatory update

Intercept Pharmaceuticals

22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept that its tentatively scheduled 9 June 2020 advisory committee meeting relating to the company’s new drug application for obeticholic acid for the treatment of liver fibrosis due to non-alcoholic steatohepatitis has been postponed. 

The postponement will accommodate the review of additional data requested by the FDA that the company intends to submit within the next week. 

The FDA has indicated that it will reach out to Intercept in the near future with a new proposed date. Intercept now anticipates that the FDA’s review of its application will extend beyond the Prescription Drug User Fee Act target action date of 26 June 2020.

Read Intercept Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , US , Timelines , Dossier