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.
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Intercept’s Ocaliva has been issued a final green light for use by the NHS to treat the rare chronic liver disease primary biliary cholangitis (PBC), which affects around one in 1,000 women over the age of 40 but is still the leading cause of liver transplantation in adult women in the UK.
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Intercept’s Ocaliva is being backed by the National Institute for Health and Care Excellence for routine NHS commissioning as a treatment for people with the chronic liver disease primary biliary cholangitis (PBC).
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