Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases
Company receives first positive opinion in the European Union for Primary Sclerosing Cholangitis
SAN DIEGO – November 18, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced that it has received positive opinions for four Orphan Drug Designations by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for LUM001. The company’s lead drug candidate, LUM001, received the first positive opinion granted by the EMA for primary sclerosing cholangitis (PSC). In addition, the company received positive opinions for LUM001 in three other rare cholestatic liver diseases including Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and primary biliary cirrhosis (PBC). This follows the Orphan Drug Designation in September by the U.S. Food & Drug Administration (FDA) Office of Orphan Product Development for LUM001 in the same indications.
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