Albireo’s A4250 Receives FDA’s Orphan Drug Designation (ODD) for Biliary Atresia
The designation is based on P-III clinical trial assessing A4250 in patients with progressive familial intrahepatic cholestasis (PFIC)
Albireo to get 10 years of market exclusivity with additional two years on completion of pediatric investigation plan (PIP) and plans to target A4250 in rare cholestatic liver diseases in 2019
A4250 is an ileal bile acid transporter (IBAT) inhibitor, indicated to treat biliary atresia and has also received ODD for progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome and primary biliary cholangitis (PBC) in the US and EU
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