Obeticholic Acid (Ocaliva): Manufacturer: Intercept Pharmaceuticals, Inc., New York, New York. Date of Approval: May 27, 2016. Indication: Obeticholic acid is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.Drug Class: Farnesoid X receptor agonist. Uniqueness of Drug: Obeticholic acid is the first agent in almost 20 years to be approved to treat PBC. The first agent, UDCA, was approved in 1997. Obeticholic acid was granted an accelerated Food and Drug Administration approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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