Ocaliva (obeticholic acid)

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Ocaliva (obeticholic acid)

How to buy Ocaliva: You can order Ocaliva (obeticholic acid) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Intercept Pharmaceuticals
Disease Primary Biliary Cholangitis (PBC)
Indication Primary biliary cholangitis (PBC)
Mode of Action Farnesoid X receptor (FXR) agonist
Approval Status EMA approved (EU); FDA approved (USA)
CAS Number 459789-99-2
HS Code 29372900
Strength 10 mg, 5 mg

Who is obeticholic acid for?

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 [1].

Recommended dose

Complete information about obeticholic acid dosage and administration can be found here: [1][4].
The recommended therapy consists of:
  • Starting Dosage: the recommended starting dosage of obeticholic acid is 5 mg orally once daily in adults who have not achieved an adequate response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA.
  • Dosage Titration: if adequate reduction in ALP and/or total bilirubin has not been achieved after 3 months of obeticholic acid 5 mg once daily and the patient is tolerating obeticholic acid, increase dosage to 10 mg once daily.
  • Maximum Dosage: 10 mg once daily.
For the management of patients with intolerable pruritus or hepatic impairment see full prescribing information [1].
Correct dosing is of the utmost importance. The FDA (Food and Drugs Administration, USA) warns that incorrect dosing in some patients with moderate to severe decreases in liver function may result in an increased risk of serious liver injury and death [5].
Consult your treating doctor for personalised dosing.

What is obeticholic acid and how does it work?

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 [1]. PBC is a chronic or long-lasting disease that causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed. This causes bile to remain in the liver, damaging liver cells over time and resulting in cirrhosis, or scarring of the liver. As cirrhosis progresses and the amount of scar tissue in the liver increases, the liver loses its ability to function. Obeticholic acid, given orally, binds to the farnesoid X receptor (FXR)—a receptor found in the nucleus of cells in the liver and intestines. FXR is a key regulator of bile acid metabolic pathways. Obeticholic acid increases bile flow from the liver and suppresses bile acid production in the liver, thus reducing the exposure of the liver to toxic levels of bile acids [2].

What is obeticholic acid's approval status?

Obeticholic acid was approved by
  • FDA (USA) on May 27, 2016 [2]
  • EMA (EU) on December 12, 2016 [3]
for the treatment of patients with primary biliary cholangitis (PBC).

The approval is based on a 12-months trial involving 216 patients with PBC who were taking UDCA for at least 12 months and were on a stable dosage for at least 3 months; or patients who were unable to tolerate UDCA and did not receive it for at least 3 months. All patients had a level of Alkaline phosphatase (ALP — an enzyme fundamental for metabolism within the liver) at least 1.67 times higher than normal (with normal being 118 U/ L for females and 124 U / L for males); or had a level of bilirubin (a brownish yellow substance produced when the liver breaks down old red blood cells and found in bile) higher than normal but less than twice as normal (with normal being 1.1 mg/ dL for females and 1.5 mg / dL for males). Patients received either obeticholic acid 10 mg for 12 months, or obeticholic acid 5 mg for the first 6 months with the option of an escalation to 10 mg for the last 6 months, or placebo. When possible patients took UDCA [1].

Patients were considered responders if after 12 months their ALP was less than 1.67 times the normal and decreased of at least 15 %, and if their bilirubin wasless or equal the normal level. At 12 months the responders on Ocaliva 10 mg were 48 % (95 % CI = 36 - 60), those on Ocaliva 5 mg with possibility to increase the dosage to 10 mg were 46 % (95 % CI = 34 - 58), and those on placebo were 10 % (95 % CI = 4 - 19) [1].

The most common side effects are tiredness and itching [3].
[1] Summary of Product Characteristics [FDA]: Ocaliva (obeticholic acid), Intercept Pharmaceuticals, May 2016.
[2] FDA News Release: FDA approves Ocaliva for rare, chronic liver disease, 31/05/2016.
[3] EMA. Human Medicines: Ocaliva (obeticholic acid), 19/12/2016, cited on 18/04/2017.
[4] Summary of Product Characteristics [EMA]: Ocaliva (obeticholic acid), Intercept Pharma Ltd., Dec. 2016.
[5] FDA. FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease, 21/09/2017.

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