Ocaliva plus bezafibrate clears FDA orphan drug hurdle for primary biliary cholangitis
The FDA granted Intercept Pharmaceuticals orphan drug designation for the fixed-dose combination of obeticholic acid and bezafibrate intended for treatment of patients with primary biliary cholangitis. Obeticholic acid (Ocaliva, Intercept Pharmaceuticals) — a farnesoid X receptor agonist — was originally FDA approved for primary biliary cholangitis (PBC) in 2016 in combination with