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
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