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Albireo receives FDA orphan drug designation for biliary atresia therapy
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Albireo Pharma received FDA orphan designation for its lead product candidate A4250, an ileal bile acid transporter inhibitor for the treatment of biliary atresia, according to a press release.
A4250 previously received an orphan drug designation from the European Commission for biliary atresia and an orphan drug designation from both the FDA and European Commission for the treatment of progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome, and primary biliary cholangitis.
“We are excited to receive orphan drug designation from the FDA for A4250 for the treatment of biliary atresia,” Ron Cooper, president and CEO of Albireo, said in the release. “This recognition continues to reinforce the widespread need to treat rare cholestatic liver diseases and the potential of A4250. We plan to expand the development of A4250 in rare cholestatic liver diseases this year.”
Cooper recently discussed Albireo’s cholestatic therapy pipeline with Healio Gastroenterology and Liver Disease at The Liver Meeting 2018, including details on A4250 as well as A3384, a proprietary formula designed to treat bile acid malabsorption disease.
Reference: www.albireopharma.com
Disclosure: Cooper is president and CEO of Albireo.