Intercept CRL Likely About OCA-Specific Concerns, Not NASH Endpoints
The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.
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Using real-world evidence and potentially a Phase III trial with a fixed-dose combination, Intercept is refocusing on fulfilling postmarketing requirements for obeticholic acid’s current indication in primary biliary cholangitis after ending development of the drug in nonalcoholic steatohepatitis due to FDA’s second rejection of accelerated approval.
Ahead of advisory committee vote on accelerated approval, agency takes a dim view of obeticholic acid's benefit-risk balance for the treatment of liver fibrosis due to NASH, citing risks of drug-induced liver injury and morbidity associated with biopsies necessary for appropriate patient selection.
Lack of long-term clinical outcomes data on a slowly progressing, common condition combined with a rapidly changing treatment space for obesity and health system cost issues may present problems for two NASH treatments even if they win accelerated approval from US FDA.