Intercept's Ocaliva Seems Headed For Black Box On Liver Injury Risk
Physician education on dosing also likely as firm hopes to show that serious adverse events in patients with less-advanced primary biliary cholangitis may not be related to the drug.
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A second FDA safety labeling update for Intercept’s Ocaliva might open a market opportunity in second-line PBC for Phase III candidates at CymaBay and Genfit.
CEO Durso says Intercept is aiming to refile its NDA by end of 2021, but several departures in recent months indicate pessimism on NASH prospects to some analysts.
A fuller look at interim Phase III data shows no path forward to accelerated approval in NASH, company says. Genfit turns focus to developing elafibranor for PBC, as well as a NASH diagnostic.