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Intercept seeks EU approval for liver disease drug Ocaliva

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Intercept seeks EU approval for liver disease drug Ocaliva

Intercept Pharmaceuticals Inc. is seeking EU approval to market Ocaliva as a treatment for nonalcoholic steatohepatitis, a fatal liver disease.

The company's application with the European Medicines Agency is based on a phase 3 trial, called Regenerate, wherein the drug improved patients' fibrosis without worsening the symptoms of nonalcoholic steatohepatitis.

The New York-based biotech also said in a Dec. 13 press release that it expects an advisory committee meeting with the U.S. Food and Drug Administration on April 22, 2020, regarding Ocaliva's label expansion. The regulator was expected to make a decision on Intercept's U.S. application by March 26, 2020, but will now likely push that forward, Intercept said.

Ocaliva is also known as obeticholic acid.