OCALIVA Efficacy: Monotherapy Data

OCALIVA Was Effective in Patients Unable to Tolerate UDCA1

  • Response Rate
  • Mean Reductions
Response Rate

In a Pooled Analysis of 2 Trials, 38% of Patients Taking OCALIVA
10 mg Once Daily Achieved a Response After 3 Months1,a

OCALIVA monotherapy efficacy–response rate
OCALIVA monotherapy efficacy–response rate
Mean Reductions

Mean Reduction in Alkaline Phosphatase Was -246 U/L for
OCALIVA 10 mg Once-daily Monotherapy After 3 Months

OCALIVA monotherapy efficacy–reduction in alkaline phosphatase
OCALIVA monotherapy efficacy–reduction in alkaline phosphatase
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See Dosing for Use With UDCA and as Monotherapy1

OCALIVA is indicated for patients with an inadequate response to UDCA or patients unable to tolerate UDCA.1

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aFifty-one PBC patients with baseline alkaline phosphatase ≥1.67x ULN and/or total bilirubin >1x ULN were evaluated for a biochemical response to OCALIVA as monotherapy (24 patients received OCALIVA 10 mg once daily and 27 patients received placebo) in a pooled analysis of data from the pivotal trial and from a randomized, double-blind, placebo-controlled, 3-month trial.1

PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.
 

OCALIVA obeticholic acid OCALIVA obeticholic acid

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Reference:

  1. OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2017.
OCALICA obeticholic acid

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OCALIVA® (obeticholic acid)

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