Intercept's liver disease drug Ocaliva approved by US FDA

31 May 2016

The US Food and Drug Administration has granted accelerated approval to liver disease drug Ocaliva (obeticholic acid), the lead product of US biopharma Intercept (Nasdaq: ICPT).

In early April, an FDA Advisory Committee had unanimously recommended accelerated approval of the drug, and the regulator announced it was following this advice on Friday, when Intercept’s share price rose by 1.3%.

Ocaliva was approved by the FDA for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

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