Albireo’s A4250 Receives FDA’s Orphan Drug Designation (ODD) for Biliary Atresia

Shots:

• Post EMA’s ODD, A4250 has received FDA’s ODD following its P-III study assessing A4250 in patients with Alagille syndrome, biliary atresia and primary biliary cholangitis (PBC)
• FDA has granted ODD to A4250 for the treatment of Alagille syndrome and primary biliary cholangitis and has also received EMA’s ODD on 18 Dec, 2018 with PRIority MEdicines (PRIME) designation for PFIC
• A4250 is an ileal bile acid transporter (IBAT) inhibitor targeted for rare pediatric cholestatic liver diseases  evaluated in P-III (NCT03566238) clinical program for patients with PFIC, subtype 1 or 2

Click here to read full press release/ article | Ref:  GlobeNewswire | Image: Sahlgrenska Science Park