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Bylvay is European Commission approved to treat progressive familial intrahepatic cholestasis.

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Published:21st Jul 2021
Albireo Pharma, Inc. announced that the European Commission has approved its cholestasis drug, Bylvay (odevixibat) for treating progressive familial intrahepatic cholestasis (PFIC).The drug is the first and only once-daily drug approved for treating all subtypes of PFIC, globally. PFIC is a rare and devastating disorder affecting young children. The disease causes progressive, life-threatening liver disease, which may progress to cirrhosis and liver failure within the first 10 years of life.

The European approval was based on data from two late-stage studies — PEDFIC 1 and PEDFIC 2 — that evaluated the drug in PFIC patients. Data from the PEDFIC 1 study demonstrated that odevixibat reduced serum bile acid responses (sBAs) and improved pruritus assessments with a single-digit diarrhea rate. Interim data from the open-label PEDFIC 2 study showed that treatment with Bylvay sustained reductions in serum bile acid as well as improvements in pruritus assessments up to 48 weeks. The treatment with the drug also improved other markers of liver function in patients.

Condition: Progressive Familial Intrahepatic Cholestasis
Type: drug

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