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  • Albireo receives positive CHMP opinion for Bylvay ...

Albireo receives positive CHMP opinion for Bylvay for treatment of progressive familial intrahepatic cholestasis (PFIC).

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Published:25th May 2021
Albireo Pharma, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Bylvay (odevixibat) for the treatment of progressive familial intrahepatic cholestasis (PFIC).

Bylvay is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) and could be the first non-surgical treatment for this rare disease. With this positive CHMP opinion, Bylvay continues on the accelerated approval path for European Commission (EC) decision on the marketing authorization application (MAA) and an anticipated launch in the second half of this year.The first-ever, non-surgical treatment that could reduce the burden of PFIC on families and children,,PFIC is a rare and devastating disorder affecting young children that causes progressive, life-threatening liver disease. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life. The most prominent and problematic ongoing manifestation of PFIC is pruritus, or intense itching, which often results in a severely diminished quality of life.

Condition: Progressive Familial Intrahepatic Cholestasis
Type: drug

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