7 April 2016 - Intercept Pharmaceuticals today announced that the U.S. FDA's Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC).

The target date for the FDA to take action under the Prescription Drug User Fee Act is May 29, 2016. The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines.

If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

Intercept is seeking accelerated approval of Ocaliva for the treatment of PBC in patients with an inadequate response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA), the only approved therapy for this disease. While UDCA has a marked impact on clinical outcomes in PBC, a substantial percentage of UDCA-treated patients have a suboptimal response or are intolerant to treatment, leaving them at significantly increased risk of an adverse outcome.

For more details, go to: http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=964146

To see the entries for obeticholic acid in the MAESTrO database, click here: https://app.maestrodatabase.com/app/registration/browse/technology/obeticholic-acid