This article is more than 5 years old. Information may no longer be current.

Albireo receives European orphan designation for biliary atresia therapy

Albireo Pharma received European Commission 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 FDA and European Commission for the treatment of progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome, and primary biliary cholangitis.

“We are pleased to receive orphan designation from the European Commission for A4250 for the treatment of biliary atresia,” Ron Cooper, president and CEO of Albireo, said in the release. “This latest regulatory milestone ... underscores the widespread need for new therapies to treat rare cholestatic liver diseases and the potential of A4250. We plan to expand the development of A4250 in rare cholestatic liver diseases in 2019.”

According to the press release, Albireo could be eligible for an additional 2 years of market exclusivity following completion of a pediatric investigation plan.

Reference: www.albireopharma.com

Disclosure: Cooper is employed by Albireo.