No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection

 
• By Joseph Haas
  
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Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.

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Reaction to Intercept's CRL varied but many NASH companies see greater opportunity

While analysts were divided on whether there were broader implications for non-alcoholic steatohepatitis (NASH) R&D following the complete response letter that Intercept Pharmaceuticals Inc. revealed on 29 June, executives from three companies with mid-stage or later NASH candidates think the US Food and Drug Administration’s concerns are specific to Intercept and its drug, obeticholic acid (OCA).

Intercept CEO Mark Pruzanski indicated during a same-day investor call that it was possible that shifting terrain in NASH –...

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