Ocaliva

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obeticholic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Ocaliva and why it is authorised in the EU

Ocaliva is used to treat adults with a liver disease known as primary biliary cholangitis.

Primary biliary cholangitis is an autoimmune condition in which there is gradual destruction of the small bile ducts in the liver. These ducts transport fluid called bile from the liver to the intestines, where it is used to help digest fats. As a result of the damage to the ducts, bile builds up in the liver causing damage to the liver tissue. This may lead to scarring and liver failure, and may increase the risk of liver cancer.

Ocaliva contains the active substance obeticholic acid. It is used together with another medicine, ursodeoxycholic acid (UDCA), in patients who do not respond sufficiently to UDCA alone, and on its own in patients who cannot take UDCA.

Primary biliary cholangitis is rare, and Ocaliva was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 July 2010.

This EPAR was last updated on 14/05/2018

Authorisation details

Product details
Name
Ocaliva
Agency product number
EMEA/H/C/004093
Active substance
Obeticholic acid
International non-proprietary name (INN) or common name
obeticholic acid
Therapeutic area (MeSH)
Liver Cirrhosis, Biliary
Anatomical therapeutic chemical (ATC) code
A05AA04
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Intercept Pharma Ltd
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
12/12/2016
Contact address
2 Pancras Square
London N1C 4AG
United Kingdom

Product information

21/03/2018 Ocaliva - EMEA/H/C/004093 - PSUSA/00010555/201706

Contents

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Pharmacotherapeutic group

BILE AND LIVER THERAPY

Therapeutic indication

Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

Assessment history

Changes since initial authorisation of medicine

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