Intercept: Complete Response Letter for Ocaliva (obeticholic acid, OCA) for primary biliary cholangitis

Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., announced that the FDA has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) - a rare, progressive disease that disproportionally affects women