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Health Canada Approves Bylvay™ (odevixibat) for the treatment of cholestatic pruritus in patients with Alagille Syndrome
Medison and Ipsen announced today that Health Canada has approved Bylvay™ (odevixibat) for the treatment of cholestatic pruritus in patients 12 months and older with Alagille Syndrome (ALGS). Bylvay was first approved in Canada in 2023 for the treatment of pruritus in patients aged 6 months or older with Progressive Familial Intrahepatic Cholestasis (PFIC), a progressive and life-threatening liver disease.
About this update from Ipsen Sa
[{"type":"text","content":"Bylvay™ is the first and only medication approved in Canada for the treatment of both Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis ","length":159,"tagName":"p"},{"type":"text","content":"TORONTO, Sept. 9, 2025 /CNW/ -- Medison and Ipsen announced today that Health Canada has approved Bylvay™ (odevixibat) for the treatment of cholestatic pruritus in patients 12 months and older with Alagille Syndrome (ALGS). Bylvay was first approved in Canada in 2023 for the treatment of pruritus in patients aged 6 months or older with Progressive Familial Intrahepatic Cholestasis (PFIC), a progressive and life-threatening liver disease.","length":451,"tagName":"p"},{"type":"image","alt":"Medison Pharma Logo","displaySize":"","headline":null,"caption":"Medison Pharma Logo","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":283,"url":"https://media.zenfs.com/en/cnwgroup.com/c8b89b7136de2f9e17b9471f29cfa68b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/NqGVsHRw9r5kiBMnhnW5bQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ5OTtjZj13ZWJw/https://media.zenfs.com/en/cnwgroup.com/c8b89b7136de2f9e17b9471f29cfa68b","width":400,"height":283}}},{"type":"text","content":"ALGS is a rare genetic disorder that can affect multiple organ systems, including the liver, heart, skeleton, eyes and kidneys.i It is estimated that ALGS is present in 1 in every 30,000 live births.ii Most of those living with ALGS experience cholestatic pruritus which can significantly impair sleep and quality of life.","length":322,"tagName":"p"},{"type":"text","content":""This approval marks another important milestone for Canadians impacted by Alagille syndrome, many of whom endure relentless itching and disrupted sleep," said Roberta Smith, President, Alagille Syndrome Alliance. "Having a novel treatment option provides much-needed hope and relief to our community."","length":322,"tagName":"p"},{"type":"text","content":"Health Canada's approval of Bylvay for ALGS was supported by data from the global Phase III ASSERT study, which demonstrated the efficacy of Bylvay in reducing cholestatic pruritus associated with ALGS within weeks of treatment. ASSERT is the world's first and only Phase III trial completed in patients with ALGS.iii The study also revealed secondary benefits,...