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Full Data For Intercept's Liver Disease Drug Show Rivals Where To Differentiate

 
• By Lucie Ellis-Taitt

Full Phase III data for Intercept Pharmaceuticals Inc.'s recently approved rare liver disease drug, Ocaliva, have highlighted potential treatment gaps for upcoming pipeline drugs, including candidates from Gilead Sciences Inc., Novartis AG, Shire Pharmaceuticals plc and GlaxoSmithKline plc.

Liver

Despite Intercept Pharmaceuticals Inc. winning US FDA approval in May for its chronic liver disease therapy Ocaliva (obeticholic acid) – which became the first new drug for the treatment of rare liver disease primary biliary cholangitis (PBC) to reach the market in more than 20 years – full Phase III data published in the New England Journal of Medicine have highlighted some flaws in the study exposing potential gaps that could be filled by upcoming pipeline drugs.

On May 27, 2016 the FDA granted accelerated conditional approval for Intercept's Ocaliva for the treatment of PBC, a chronic...

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