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

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

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

Shots:
  • 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

Click here to read full press release/ article | Ref: Albireo Pharma | Image: Axios

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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