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Intercept’s NASH Approval Timeline Shuffled Again With FDA Delay

 
• By Joseph Haas

The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.

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Intercept's timeline for OCA approval in NASH remains uncertain

The picture for Intercept Pharmaceuticals Inc.’s obeticholic acid (OCA) and the expected first approval of a drug for non-alcoholic steatohepatitis (NASH) grew hazier on 22 May when the company said a US Food and Drug Administration advisory committee review planned for 9 June has been postponed following the agency’s request for more data. Intercept said it will submit the information in the next week, but an approval decision for OCA likely will occur after the new drug application’s 26 June action date.

This is not the first delay on the road to approval for OCA – a farnesoid X receptor (FXR) agonist that was the first drug to post successful Phase III...

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