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Intercept CRL Likely About OCA-Specific Concerns, Not NASH Endpoints

 
• By Joseph Haas

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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The complete response for OCA may have opened up the NASH race

A major question arising from the US Food and Drug Administration’s rejection of Intercept Pharmaceuticals Inc.’s new drug application for obeticholic acid (OCA) in non-alcoholic steatohepatitis (NASH) on 29 June was whether the goalposts for approval in the disease, which has yet to see a therapy approved, were being shifted for all companies in the space. However, the early sense from analysts is that the agency was expressing concerns specific to OCA’s risk-benefit profile, rather than about the currently identified surrogate endpoints for NASH.

During an investor call to discuss the FDA complete response letter, Intercept CEO Mark Pruzanski said he was surprised by the agency’s decision, that Intercept had no indication that the...

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