MEDICAL ASSOCIATIONS
(ACG AND AASLD)
RECOMMEND OCALIVA
ACG Expert Opinion and AASLD Guidance recommend OCALIVA for PBC patients who have not achieved their treatment goal with UDCA alone or cannot tolerate UDCA1,2 SEE THE GUIDANCE

OCALIVA Efficacy: Monotherapy Data

OCALIVA Was Effective in Patients Unable to Tolerate UDCA3

  • 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 Months3,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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For help enrolling: 1-844-622-4278

For help enrolling: 1-844-622-4278

See Dosing for Use With UDCA and as Monotherapy3

OCALIVA is indicated for patients with an inadequate response to UDCA or patients unable to tolerate UDCA.3

See the dosing schedule

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.3

AASLD, American Association for the Study of Liver Diseases; ACG, American College of Gastroenterology; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.
 

OCALIVA obeticholic acid OCALIVA obeticholic acid

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References:

  1. Younossi ZM, Bernstein D, Shiffman ML, et al. Diagnosis and management of primary biliary cholangitis. Am J Gastroenterol. 2019;114(1):48-63. doi: 10.1038/s41395-018-0390-3.
  2. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419. doi:10.1002/hep.30145.
  3. OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2018.
OCALICA obeticholic acid

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OCALIVA® (obeticholic acid)

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