FDA denies Ocaliva full approval in primary biliary cholangitis; safety data still in play
The FDA issued a complete response letter to Intercept Pharmaceuticals indicating it cannot grant full approval to the company’s supplemental new drug application for Ocaliva as a treatment for primary biliary cholangitis. As Healio previously reported in September, the FDA Gastrointestinal Drug Advisory Committee voted 13 to 1 with no abstentions that the benefits of Ocaliva (obeticholic