Intercept Gifts Shareholders With NASH Refiling
Nearly two-and-a-half years after an FDA complete response letter stalled obeticholic acid’s path to the first approval in non-alcoholic steatohepatitis, Intercept refiled its NDA on 23 December.
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An FDA advisory committee’s “no” votes for Intercept’s obeticholic acid in non-alcoholic steatohepatitis could augur tough reviews for other NASH candidates. But some could enjoy smoother regulatory tides than OCA.
Company tells advisory committee it is unsure of continuing on to collect Phase III outcomes data in NASH without accelerated approval, which the panel voted against.
The cost-effectiveness group voted by a slight margin that Madrigal’s non-alcoholic steatohepatitis drug offers benefit above lifestyle changes alone, but decisively that Intercept’s candidate does not.