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Intercept Unlikely To Refile OCA For NASH Before Late 2021

 
• By Joseph Haas

Once determined to resubmit its NDA by the end of 2020, Intercept now says talks with the FDA have presented a new path to approval in non-alcoholic steatohepatitis that could mean refiling sometime in 2021.

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Intercept can see a path forward in NASH, but it will take a while

Intercept Pharmaceuticals, Inc.’s announcement that it hopes to refile the new drug application for obeticholic acid, its non-alcoholic steatohepatitis drug candidate, sometime in 2021 dramatically changes the timeline for the drug’s potential approval, but investors responded positively to the news, perhaps indicating relief that a clear path to approval now seems to be in place.

During the company’s third quarter earnings call on 9 November, CEO Mark Pruzanski said a type A end-of-review meeting with the US Food and Drug Administration in October had been...

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