Ipsen’s Kayfanda (Odevixibat) Gains the CHMP’s Positive Opinion to Treat Cholestatic Pruritus in Alagille Syndrome (ALGS) 

        Shots:   

• The CHMP’s positive opinion of Kayfanda to treat cholestatic pruritus in ALGS individuals (≥6mos.) was based on P-III (ASSERT) study. EC’s decision is anticipated in Q3’24 

• The P-III (ASSERT) study assessed the safety & efficacy of Kayfanda (120µg/kg/day) vs PBO for 24wks.to relieve itch in ALGS patients (n=52; 0-17yrs.) across North America, EU, the Middle East & the Asia Pacific regions  

• Study reached its 1EP, showing improved pruritus after 6mos. (90% were itch responders) & 2EP, showing reduction in serum bile acid concentration after 20-24wks. and improved sleep parameters at wks.1-4 that sustained till wk.24   

Ref: Ipsen  | Image: Ipsen| Press Release

Related News:- Johnson & Johnson’s Yuvanci (macitentan and tadalafil) Receives the CHMP’s Positive Opinion for Treating Pulmonary Arterial Hypertension (PAH) 

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