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Ipsen and Medison Pharma’s Bylvay receives Health Canada approval for the treatment of pruritus due to PFIC

Health Canada has approved Ipsen and Medison Pharma’s Bylvay (odevixibat) 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. Bylvay is the first medication approved in Canada for the treatment of pruritus in patients aged six months or older with PFIC.

Medison and Ipsen are part of a multiregional partnership in both Canada and Israel to bring Bylvay, a highly innovative therapy for the treatment of pruritus due to PFIC, offering new hope for patients suffering from this rare disease, and their families.

“At Medison, accelerating patients’ access to innovative treatments is leading all that we do, so we are pleased and proud to bring Bylvay to patients in Canada,” said Gil Gurfinkel, CEO at Medison Pharma. “We work hard, leveraging our multi-regional platform, to be the partner-of-choice for emerging biotech companies seeking to make their products available in international markets.”

“Health Canada’s authorization of Bylvay brings an important medicine to Canadians living with PFIC and their families,” said Stewart Campbell, Executive Vice President and President of North America, Ipsen. “Bringing new medicines to new markets where unmet need exists illustrates Ipsen’s mission to improve patient lives. We are pleased to work with Medison to get Bylvay to prescribers as soon as possible.”

“I hope that the availability of Bylvay will immediately change the treatment paradigm for PFIC patients in Canada, providing physicians with a non-surgical option to help care for children with PFIC suffering from pruritus,” said Dr. Binita Kamath, Division Head (interim), Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children in Toronto. “Being involved with the clinical investigation of odevixibat, I have firsthand experience with the value this therapy can offer families – including potentially better outcomes.”


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