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.
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Zydus Looks To NASH Trials In Turkey, gVascepa Launch In The US
Zydus, the only Indian company with an NCE for a range of chronic liver diseases, will add Turkey to the list of trial locations for NASH. It is also working “aggressively” to launch a generic to Amarin’s Vascepa after Revlimid and Trokendi generics drove record US sales in the fourth quarter
Intercept’s OCA Facing Extended Approval Wait In NASH As Known Risks Swamp Uncertain Benefits
Obeticholic acid clinical outcomes data from Phase III trial are needed before approval, US FDA advisory committee says, but Intercept suggests future of ongoing study is in doubt if accelerated approval in nonalcoholic steatohepatitis is not forthcoming now.
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.