FDA approves Ocaliva for primary biliary cholangitis

The US Food and Drug Administration (FDA) has granted accelerated approval to Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

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