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.
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When the first non-alcoholic steatohepatitis drugs reach market, the health cost watchdog says payers will be justified in setting step-therapy including weight-management efforts, while early prescribing should be by specialists.
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.
Competing with Madrigal in the THRβ agonist class in non-alcoholic steatohepatitis, Viking’s VK2809 reports stronger efficacy and better safety and tolerability than resmetirom at that stage.