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NEWS

Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients

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 regionsTrial met its 1EP of improved pruritus…
September 10, 2025

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NEWS

Mirum Pharmaceuticals’ Livmarli (maralixibat) Receives the CHMP’s Positive Opinion for Progressive Familial Intrahepatic Cholestasis (PFIC) 

   Shots: The CHMP has granted positive opinion to Livmarli (oral solution) for PFIC patients (age: ≥3mos.) along with COMP for maintaining ODD. EC’s decision is anticipated in Q3’24  The opinions were supported by the P-III (MARCH) trial involving 93 patients with PFIC types (PFIC1, PFIC2, PFIC3, PFIC4, PFIC6 & unidentified mutational status), showing decreased…
May 31, 2024

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