Intercept Unlikely To Refile OCA For NASH Before Late 2021

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 “constructive” and that after reviewing minutes from the meeting, he believes Intercept can refile its NDA for OCA to treat NASH fibrosis by