University of Iowa

Intercept Pharmaceuticals Receives FDA Approval for Ocaliva®

Intercept Pharmaceuticals, Inc. received FDA approval for the orphan drug Ocaliva – one of only 22 NMEs (New Molecular Entities) to receive approval by the FDA in calendar year 2016!  It is indicated for the treatment of Primary Biliary Cholangitis (PBC) in patients with an inadequate response to Ursodeoxycholic acid (UDCA) or as monotherapy – PBC is a disease for which there has not been a significant new treatment in nearly 20 years.  Intercept is a long-standing client of UIP’s.  UIP’s analytical laboratory is a laboratory of record in their NDA for this drug product.