Intercept Gifts Shareholders With NASH Refiling
Executive Summary
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.
You may also be interested in...
What Does The Negative FDA Review For Intercept’s OCA Hold For Other NASH Drugs?
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.
Will Intercept Drop OCA For NASH Following Negative FDA Panel Review?
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.
ICER’s NASH Panel Shows Some Enthusiasm For Resmetirom, None For OCA
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.