Shots:
- Health Canada has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in pts (≥12mos.) with Alagille Syndrome (ALGS)
- Approval was based on P-III (ASSERT) trial assessing Bylvay (120µg/kg, QD) vs PBO in ALGS pts for 24wks. across North America, EU, Middle East, & Asia Pacific regions
- Trial met its 1EP of improved pruritus at 6mos., & achieved its 2EP of reduced bile acid concentration at Wks. 20-24, with benefits also observed across multiple sleep parameters, incl. % of days with sleep-onset difficulty & daytime tiredness score
Ref: PR NewsWire | Image: Medison & Ipsen| Press Release
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