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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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