Albireo’s Bylvay (odevixibat) Receives the US FDA’s Approval for the Treatment of Progressive Familial Intrahepatic Cholestasis

July 21, 2021 Auto Bot regulatory 0

Shots:

  • The approval is based on P-III PEDFIC 1 & 2 studies evaluating Bylvay (qd) vs PBO in patients with pruritus in PFIC. The PEDFIC 1 study met its 1EPs i.e the therapy showed a low incidence of diarrhea or frequent bowel movements (9.5% vs 5.0%)
  • The PEDFIC 2 study showed sustained reductions in serum bile acids & improvements in pruritus assessments, growth & other markers of liver function @ 48 wks. & well tolerated across both studies
  • Bylvay is expected to be launch immediately in the coming days & is also being evaluated in a P-III BOLD trial for biliary atresia & P-III ASSERT trial for Alagille syndrome while results from the BOLD & ASSERT trial is expected in 2024 & 2022

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

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