Leerink Remains Cautious on Intercept Pharma (ICPT) Amid Positive CHMP Opinion on Ocaliva
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Intercept Pharma (ICPT) Gains Positive CHMP Opinion for Ocaliva
October 14, 2016 7:37 AM EDTIntercept Pharmaceuticals, Inc. (Nasdaq: ICPT) announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization of the Companys Marketing Authorization Application (MAA) for obeticholic acid (OCA), an FXR agonist, for the treatment of primary biliary cholangitis (PBC) conditional to the company providing further data post-approval to confirm benefit.
Ursodeoxycholic acid (UDCA) is currently the only approved medication for the treatment of PBC in Europe and is the standard of care for all PBC patients. However, a substantial... More
