Intercept Pharmaceuticals Inc. is seeking marketing approval from the U.S. Food and Drug Administration for its liver disease drug Ocaliva.
The application is based on results from a phase 3 study called Regenerate, in which Ocaliva reduced inflammation, scarring and fat buildup in the liver due to nonalcoholic steatohepatitis, or NASH.
NASH is a form of nonalcoholic fatty liver disease in which the liver is inflamed and liver cells are damaged. Scarring of the liver causes it to malfunction, and serious complications include bleeding, organ failure and cancer.
The New York-based biotech plans to submit an application with the European Medicines Agency in the fourth quarter of this year for the marketing approval of Ocaliva in the EU.
The FDA granted accelerated approval to the drug in May 2016 as a treatment for another liver disease called primary biliary cirrhosis, which destroys small ducts in the organ.
