Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint

 
• By Joseph Haas

Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.

Failed experiment
Failure in cirrhotic NASH will not scuttle Intercept's overall plans in the disease • Source: Shutterstock

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