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Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases
Date:11/18/2013

SAN DIEGO, Nov. 18, 2013 /PRNewswire/ -- 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.

"The EMA's recognition of LUM001 as a potential treatment for the thousands of patients who suffer from these debilitating, rare liver diseases is another important step in our development plans," said Mike Grey, Lumena's chief executive officer and president. "We will continue to work diligently to develop LUM001 for the patients in serious need of safe, non-invasive therapeutic options to prevent progressive liver damage and the accompanying devastating symptoms."  

Cholestatic liver diseases, such as ALGS, PFIC, PBC and PSC, result in imp
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SOURCE Lumena Pharmaceuticals
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