A study of INT-747 (6-ethyl chenodeoxycholic acid [6-ECDCA]) in combination with ursodeoxycholic acid (UDCA [URSO]) in patients with primary biliary cirrhosis (PBC)
Phase of Trial: Phase II
Latest Information Update: 25 May 2017
At a glance
- Drugs Obeticholic acid (Primary) ; Ursodeoxycholic acid
- Indications Primary biliary cirrhosis
- Focus Therapeutic Use
- Sponsors Intercept Pharmaceuticals
- 25 May 2017 According to an Intercept Pharmaceuticals media release, the Health Canada has granted a conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC), when used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Data from the study supported the application.
- 18 Mar 2017 Results evaluating evidences from NCT01904539, NCT01473524, NCT00550862, NCT00570765 trials to recommend appropriate dosing in treatment of primary biliary cholagitis, presented at the 118th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
- 19 Sep 2016 Company has filed a New Drug Submission to Health Canada, seeking Canadian marketing approval for obeticholic acid in combination with ursodeoxycholic acid for the treatment of primary biliary cholangitis, based on the efficacy and safety data from three trials as reported in an Intercept Pharmaceuticals media release.