Intercept's NASH hopeful gets preliminary thumbs down in FDA briefing docs
The FDA has once again raised safety concerns around the use of Intercept’s obeticholic acid in NASH, concluding in briefing documents ahead of an upcoming advisory committee meeting that it “cannot justify OCA use in NASH subjects with Stage 2 or 3 fibrosis.”
Intercept’s push for an accelerated approval was first rejected by the FDA in 2020 after multiple delays. The drug is marketed as Ocaliva in primary biliary cholangitis. At the time, regulators said they were uncertain if its benefit based on a surrogate endpoint, reduction in liver fibrosis, was enough to outweigh potential risks in NASH, according to Intercept. Executives, however, said they were blindsided.
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