Albireo Granted Orphan Drug Designation by FDA For Lead Product Candidate A4250 for Treatment of Biliary Atresia
Albireo Pharma, Inc. (ALBO)
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Source: GlobeNewswire
Expands A4250 development potential in rare cholestatic liver diseases Biliary atresia is among the most common rare pediatric liver diseases and is the most common pediatric liver disease for which transplants are done ?BOSTON, Jan. 22, 2019 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to lead product candidate A4250, an ileal bile acid transporter (IBAT) inhibitor, for the treatment of biliary atresia, a rare and life-threatening liver disease with no approved pharmacologic treatment option. A4250 now holds orphan drug designations from both the FDA and EMA for the treatment of progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome, biliary atresia and primary biliary cholangitis (PBC). The FDA grants orphan drug designation to novel drugs that seek to treat a r
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