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.