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Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases
Date:9/26/2013

SAN DIEGO, Sept. 26, 2013 /PRNewswire/ -- Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced that it has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) Office of Orphan Product Development for LUM001, the company's lead drug candidate. LUM001 received Orphan Designation in four rare cholestatic liver diseases including Alagille syndrome (ALGS); progressive familial intrahepatic cholestasis (PFIC); primary biliary cirrhosis (PBC); and primary sclerosing cholangitis (PSC).

Cholestatic liver diseases, such as ALGS, PFIC, PBC and PSC, result in impaired bile acid flow and retention of bile acids in the liver, leading to progressive liver damage that can cause liver failure. By reducing serum bile acids with a once-daily oral drug, LUM001 may offer a novel therapeutic approach to reducing elevated bile-acid levels, preventing liver damage and alleviating severe itching, which is generally the most debilitating symptom afflicting patients with these diseases.

"Orphan Drug Designation from the FDA allows us to pursue an accelerated pathway for development of LUM001 so we can deliver new drug treatments for the patients in desperate need," said Alejandro Dorenbaum, M.D., chief medical officer of Lumena. "Curre
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SOURCE Lumena Pharmaceuticals
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