Intercept Pharmaceuticals is withdrawing its EU marketing authorization application (MAA) for obeticholic acid (OCA), an investigational treatment for liver fibrosis due to nonalcoholic steatohepatitis (NASH) that also suffered a setback in the US but which the company hopes to resubmit in that jurisdiction soon.
Intercept Withdraws EU NASH Drug Filing But May Retry
New data that is being collected to support a US resubmission for Intercept’s obeticholic acid might also be used to support a resubmission to the European Medicines Agency.
