Intercept Pharmaceuticals, Inc. has announced that it has achieved two important regulatory milestones related to its lead candidate, obeticholic acid (OCA).

The company has completed submitting a rolling new drug application with the FDA (initiated in Dec 2014) for an accelerated approval for OCA for the above indication. Additionally, the company's marketing authorization application for the candidate has been accepted for review for the same indication by the European Medicines Agency.

Intercept Pharmaceuticals is looking to get OCA (in combination with ursodeoxycholic acid (UDCA)) approved for the treatment of primary biliary cirrhosis (PBC) in patients who respond inadequately to UDCA or as monotherapy in those unable to tolerate UDCA.

For more details, go to: http://www.nasdaq.com/article/intercept-pharmaceuticals-files-for-oca-in-us-and-europe-analyst-blog-cm492285