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

  | Ref: Globe Newswire | Image: Albireo Pharma