Accelerated approval for Intercept's Ocaliva for PBC unanimously recommended by US FDA committee

8 April 2016

A US Food and Drug Administration Advisory Committee has unanimously recommended accelerated approval of Ocaliva (obeticholic acid) for the treatment of liver disease primary biliary cholangitis (PBC).

Although the FDA is not bound by the committee’s guidance on the drug, which is being developed by US biopharma Intercept Pharmaceuticals (Nasdaq: ICPT), the advice is taken into consideration during the regulator’s review.

The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is May 29. If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

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