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Due to Risk of Serious Liver Injury - FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis (PBC) Patients with Advanced Cirrhosis americanpharmaceuticalreview
June 01, 2021
The U.S. FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm.
Successive drug launches will drive growth of NASH market in seven major markets: GlobalData expresspharma
November 24, 2020
The NASH market will undergo a very rapid growth, at a compound annual growth rate (CAGR) of 68.8 per cent from 2019 to 2029.
Cadila Pharma launches Obetocad, generic obeticholic acid for liver therapy expresspharma
September 18, 2020
Obetocad can be used as a monotherapy or along with UDCA for treatment of patients with primary biliary cholangitis who are unresponsive to UDCA therapy.
Intercept reports additional positive data for Ocaliva in late-stage NASH trial firstwordpharma
April 12, 2019
Intercept reports additional positive data for Ocaliva in late-stage NASH trial.
FDA warning on Intercept’s Ocaliva after patient deaths pharmatimes
September 25, 2017
US regulators have issued a safety communication warning of the risk for serious liver injury and death from incorrect dosing of Intercept Pharmaceuticals' Ocaliva in patients with primary biliary cholangitis.
19 deaths from liver drug causes Intercept shares to tumble pharmafile
September 25, 2017
Intercept Pharmaceuticals had sparked major concerns over its drug, Ocaliva, after it revealed that 10 people had died as a result of its treatment – that concerned escalated as the FDA announced 19 people in total had died.
NICE approves Intercept’s Ocaliva for use by UK's NHS pharmaceutical-technology
March 07, 2017
The National Institute for Health and Care Excellence (NICE) in the UK has approved Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland.