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